CN114099947A - Medical device and medical system - Google Patents

Abstract

The invention relates to a medical device and a medical system, the medical device comprises a flexible pulse generator which is used for being implanted on a skull, does not need to be opened on the body of a patient and at multiple positions of the head, does not need to build a subcutaneous tunnel from the head to the neck, simplifies the operation and shortens the operation time, and meanwhile, the flexible pulse generator can be well matched with the skull, and the discomfort of the patient caused by the fact that the center and the edge of the flexible pulse generator protrude out of the scalp too much is avoided.

Description

Medical device and medical system

Technical Field

The invention relates to the technical field of medical instruments, in particular to a medical device and a medical system.

Background

Implantable active medical devices are now widely used for the treatment of various conditions, especially physiological and psychological diseases, and the treatment method has more excellent and direct curative effects compared with the traditional treatment method. One of the implantable active medical devices is a nerve electrical stimulator, which delivers electrical pulses to the nerve tissue via electrodes to improve the normal skill operation of the human body. For example, the implanted Deep Brain nerve pole electrode (DBS) is common, and can effectively improve limb control and coordination ability of parkinson patients. Parkinson's Disease (PD) is a common degenerative Disease of the nervous system, primarily treated by drugs in early and middle stages. However, with the increasing dosage of the intervention drugs and the development of diseases, the risks of side effects of the drugs, the psychological burden of the patients and the drug resistance of the patients to the drugs are increased. Therefore, in the middle and advanced stages of Parkinson's disease, surgical treatment is an effective supplementary means of drug therapy. The existing surgical treatment has two main modes, one is a nerve nucleus damage operation, and the other is a deep brain nerve electrical stimulation operation. Among them, deep brain nerve electrical stimulation is the first choice for surgical treatment because of its micro-trauma, safety and effectiveness.

A prior art deep brain neurostimulation electrode system is shown in fig. 1 and includes a pulse generator (often abbreviated IPG)10, an extension wire 20 and an electrode 30. When a patient has symptoms of resting tremor, gait disturbance, etc. on one side of the body (only the left or right side of the body), it is often necessary to implant a pulse generator 10, an extension wire 20 and an electrode 30. If the patient's symptoms are bilateral, it is usually necessary to implant one pulse generator 10, two extension wires 20, and two electrodes 30, as shown in fig. 2. The electrodes 30 are typically implanted about 10cm into the brain, with the remainder being embedded subcutaneously in the head, with the other end being placed behind the ear in connection with a subcutaneous extension wire 20, with the extension wire 20 being connected to the pulse generator 10. The pulse generator 10 generates an electrical signal that is transmitted through the subcutaneous extension lead 20 to the electrode 30 and on to the target region of the brain. In performing the implantation, the pulse generator 10 is implanted at a chest location beneath the patient's clavicle and a tunneling channel is then created via a subcutaneous tunneling burr. The distal end of the extension lead 20 is connected with the electrode 30, the electrode 30 reaches the position of the skull opening through the tunneling channel and is implanted into the brain tissue to treat a target area, the electrode 30 is fixed on the skull through a skull fixing device, the middle section of the extension lead 20 is placed in the tunneling channel, and the proximal end of the extension lead 20 is connected with the pulse generator 10.

The existing brain deep nerve stimulation electrode comprises a plurality of functional components, and each functional component is distributed on the chest, the neck and the head of a patient, so that a plurality of openings are required to be formed in the chest, the head and the top of the skull of the patient during operation, the difficulty and risk of the operation are relatively large, the wound area of the patient is wide, and the postoperative recovery time is long. After the deep brain nerve stimulation electrode is implanted into a patient, the extension lead is connected with the pulse generator and the electrode through the tunneling channel of the neck, so that great influence is generated on the daily life of the patient, meanwhile, the stress of the extension lead is also generated by the daily neck and head activities of the patient, and the risk of damage and failure of the extension guide is increased.

Disclosure of Invention

The invention aims to provide a medical device and a medical system, which are integrally implanted on the cranium of a patient, do not need to open the body and the head of the patient and form subcutaneous tunnels on the head and the neck of the patient, reduce the operation difficulty and the operation risk, have small wound on the patient, are convenient for the postoperative recovery of the patient, can better adapt to the shape of the cranium and reduce the discomfort of the patient.

To achieve the above object, the present invention provides a medical device comprising a flexible pulse generator for generating an electrical pulse;

the flexible pulse generator comprises a flexible shell, wherein the flexible shell comprises a bottom wall and a top wall which are oppositely arranged, and a side wall which connects the bottom wall and the top wall; the bottom wall and the top wall are same in shape and are coaxially arranged, and the area of the bottom wall is larger than that of the top wall; the outer surface of the side wall is in a curved surface shape protruding outwards.

Optionally, the flexible pulse generator further comprises a pulse generating module packaged inside the flexible housing, the pulse generating module comprises an inductor, a flexible battery and a flexible circuit board, the inductor is connected with the flexible battery, and the flexible battery is connected with the flexible circuit board; the inductor is used for carrying out wireless communication with the outside so as to receive an external control signal, and the flexible battery and the flexible circuit board are used for generating the electric pulse together according to the control signal.

Optionally, the flexible battery is a rechargeable battery, and the inductor is further configured to receive external relay energy to charge the flexible battery.

Optionally, the bottom wall and the top wall are both circular.

The flexible shell is provided with at least one fixing device for fixing the flexible pulse generator on a predetermined object.

Optionally, the number of the fixing devices is two, and the two fixing devices are symmetrically arranged on the flexible casing.

Optionally, the securing means comprises an extension arm extending radially outwardly of the flexible pulse generator from a side wall of the flexible housing.

Optionally, at least one electrode interface is disposed on the sidewall for connecting with an electrode.

Optionally, a waterproof structure is arranged at the electrode interface.

Optionally, the extension arm comprises an upper arm and a lower arm, the distance between the upper arm and the lower arm decreasing in a direction away from the flexible housing.

To achieve the above object, the present invention also provides a medical system comprising an electrode and a medical device as described in any of the previous items, the electrode being connected to the pulse generator for applying the electrical pulse to the target tissue.

Compared with the prior art, the medical device and the medical system have the following advantages:

the medical device comprises a flexible pulse generator for generating an electrical pulse; the flexible pulse generator comprises a flexible shell, wherein the flexible shell comprises a bottom wall and a top wall which are oppositely arranged, and a side wall which connects the bottom wall and the top wall; the bottom wall and the top wall are same in shape and are coaxially arranged, the area of the bottom wall is larger than that of the top wall, and the outer surface of the side wall is in an outward protruding curved surface shape. The flexible pulse generator is implanted on the skull of a patient, on one hand, openings are not needed on the body and at multiple positions of the head of the patient, and a subcutaneous tunnel is not needed to be formed on the head and the neck of the patient, so that the operation difficulty and risk are reduced, the postoperative recovery of the patient is facilitated, and the adverse effect of the daily activities of the patient on the medical device is avoided; on the other hand, the area of the bottom wall of the flexible pulse generator is smaller than that of the top wall, and the flexible pulse generator is of a bendable flexible structure, so that the flexible pulse generator can better adapt to the shape of the skull, and the discomfort of a patient is reduced.

Drawings

FIG. 1 is a schematic diagram of a deep brain nerve stimulation electrode of the prior art;

FIG. 2 is a schematic illustration of a prior art deep brain nerve stimulation electrode implanted in a patient, illustrating both electrodes co-implanted;

FIG. 3 is a schematic diagram of a flexible pulse generator and electrodes of a treatment system according to an embodiment of the present invention integrally implanted on the top of a patient's skull;

FIG. 4 is a schematic top view of the flexible pulse generator and electrodes of the treatment system according to one embodiment of the present invention implanted integrally on the crown of a patient's skull;

FIG. 5 is a schematic external view of a flexible pulse generator of a treatment apparatus according to an embodiment of the present invention;

FIG. 6 is an exploded schematic view of a flexible pulse generator of a treatment apparatus provided in accordance with an embodiment of the present invention;

FIG. 7 is a schematic illustration of a waterproof structure within an electrode interface of a flexible pulse generator of a treatment system provided in accordance with an embodiment of the present invention;

FIG. 8 is a schematic diagram of an electrode configuration of a treatment system provided in accordance with an embodiment of the present invention;

FIG. 9 is a schematic view of an electrode of a treatment system provided in accordance with an embodiment of the present invention secured to the crown by a skull lock.

[ reference numerals are described below ]:

100-a flexible pulse generator;

111-bottom wall, 112-top wall, 113-side wall, 114-extension arm, 114 a-upper arm, 114 b-lower arm, 115-electrode interface, 116-silicone ring;

121-a sensor; 122-a flexible battery; 123-flexible circuit board;

200-electrodes;

210-a distal electrode portion;

211-directional electrode contacts, 212-developing element;

220-middle section;

221-a guide wire;

230-a proximal electrode portion;

231-retaining ring, 232-electrode connection contact;

300-skull lock.

Detailed Description

The embodiments of the present invention are described below with reference to specific embodiments, and other advantages and effects of the present invention will be easily understood by those skilled in the art from the disclosure of the present specification. The invention is capable of other and different embodiments and of being practiced or of being carried out in various ways, and its several details are capable of modification in various respects, all without departing from the spirit and scope of the present invention. It should be noted that the drawings provided in the present embodiment are only for illustrating the basic idea of the present invention, and the components related to the present invention are only shown in the drawings rather than drawn according to the number, shape and size of the components in actual implementation, and the type, quantity and proportion of the components in actual implementation may be changed freely, and the layout of the components may be more complicated.

Furthermore, each of the embodiments described below has one or more technical features, and thus, the use of the technical features of any one embodiment does not necessarily mean that all of the technical features of any one embodiment are implemented at the same time or that only some or all of the technical features of different embodiments are implemented separately. In other words, those skilled in the art can selectively implement some or all of the features of any embodiment or combinations of some or all of the features of multiple embodiments according to the disclosure of the present invention and according to design specifications or implementation requirements, thereby increasing the flexibility in implementing the invention.

As used in this specification, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise, and the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either fixedly connected, detachably connected, or integrally connected. Either mechanically or electrically. Either directly or indirectly through intervening media, either internally or in any other relationship. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

One of the objects of the present invention is to provide a medical device comprising a flexible pulse generator for generating electrical pulses for achieving deep brain electrical stimulation. The flexible pulse generator is connected with the electrodes and then integrally implanted in the skull of a patient, particularly on the top of the skull. Need not like this at patient's head and on one's body many places opening, reduce the wound to the patient, be favorable to patient's postoperative to resume, also need not to establish simultaneously from patient's head to the subcutaneous tunnel of neck, reduce medical device is to patient's daily life's interference, also avoids patient's daily activity to cause the damage to medical device. The flexible pulse generator is integrally configured into a flexible structure, can be bent and deformed to adapt to the shape of a skull, and avoids discomfort and adverse reaction of a patient caused by overhigh protruding scalp at the central part and the edge part after being implanted on the skull. Furthermore, the shape of the flexible pulse generator is designed, so that the folds of the flexible pulse after bending are reduced, and the flexible pulse generator is more attached to the skull.

The medical system comprises the medical device and an electrode, wherein the electrode is connected with the flexible pulse generator and acts the electric pulse on a target point to perform electric stimulation treatment.

To further clarify the objects, advantages and features of the present invention, a more particular description of the invention will be rendered by reference to the appended drawings. It is to be noted that the drawings are in a very simplified form and are not to precise scale, which is merely for the purpose of facilitating and distinctly claiming the embodiments of the present invention. The same or similar reference numbers in the drawings identify the same or similar elements.

Fig. 3 shows a schematic structural diagram of a flexible pulse generator and an electrode of the medical system implanted together on the top of the skull, and fig. 4 shows a schematic structural diagram of a flexible pulse generator and an electrode of the medical system implanted together on the top of the skull in a top view. Referring to fig. 3 and 4, the medical device includes a flexible pulse generator 100, and the medical system includes the medical device and an electrode 200, wherein the electrode 200 is used for directly connecting with the flexible pulse generator 100. The medical system is used for realizing deep brain electrical stimulation, wherein the flexible pulse generator 100 is used for generating electric pulses and delivering the electric pulses to the electrode 200, and the electrode 200 delivers the electric pulses to a target position. In this embodiment, the flexible pulse generator 100 and the electrode 200 are integrally implanted on the head of the patient, in particular on the cranial crown. The electrodes 200 are directly connected to the flexible pulse generator 100 without the need for long extension wires. The flexible pulse generator 100 is a flexible structure that can be bent to conform to the shape of the skull.

Fig. 5 shows an external view of the flexible pulse generator 100, and fig. 6 shows an exploded view of the flexible pulse generator 100. As shown in fig. 5 and 6, the flexible housing includes a bottom wall 111 and a top wall 112 disposed opposite to each other, and a side wall 113 connecting the bottom wall 111 and the top wall 112. In the non-implanted state, the bottom wall 111 and the top wall 112 of the flexible pulse generator 100 are identical in shape and are coaxially arranged, the area of the bottom wall 111 is larger than that of the top wall 112, and the outer surface of the side wall 113 is in a curved shape protruding outwards, so that the bottom wall 111, the bottom wall 112 and the side wall 113 are smoothly and transitionally connected. During operation, a skull groove is formed in the skull, and then the flexible pulse generator 100 is placed in the skull groove, wherein the bottom wall 111 is closer to the bottom of the skull groove. The flexible pulse generator 100 in this shape can reduce wrinkling after bending to better conform to the skull. Further, the bottom wall 111 and the top wall 112 are circular in shape, i.e. the overall shape of the flexible pulse generator 100 is drum-shaped, which provides better fit with the skull. The flexible structure can deform along with the difference of the use environment, so that the flexible structure is suitable for different environments.

In this embodiment, the flexible pulse generator 100 is implanted on the skull cap, and there is no need to form openings on the body and at multiple positions of the head of the patient, and there is no need to form subcutaneous tunnels on the head and the neck of the patient, so that the difficulty and risk of the operation are reduced, the wound on the patient is reduced, and the postoperative recovery of the patient is utilized. In addition, recent studies have found that shortening the surgical time can increase the accuracy of implant surgery and improve postoperative disease relief. Specifically, the intracranial environment changes during and after the operation due to the influence of factors such as intracranial pressure and cerebrospinal fluid, and the longer the operation time is, the larger the difference is, the more easily the implantation position deviates during or after the operation, and the treatment effect is further influenced. By adopting the flexible pulse generator 100, the operation steps can be obviously reduced, the operation time can be shortened, the influence on the intracranial environment can be reduced, and the treatment effect can be further improved, because the flexible pulse generator only needs to be opened at the skull top, does not need tunneling, and does not need the suture and subsequent treatment at a plurality of positions. Moreover, the flexible pulse generator 100 is implanted in the head of a patient, so that the influence on the postoperative daily life of the patient is reduced, the damage and failure risk of the daily activities of the patient on a treatment system are reduced, and the electrode performance and the service life are improved. In particular, by shaping the flexible pulse generator 100 to more closely match the shape of the skull after bending, patient discomfort is reduced.

In this embodiment, the flexible enclosure may include a flexible cover layer and a soft filler. A flexible covering layer with a proper shape is manufactured according to the skull structure of a patient, then the internal structure of the pulse generator is placed in the flexible covering, and the soft filler is filled in the gap between the flexible covering layer and the internal structure. The flexible covering layer can be made of flexible glass or bendable soft ceramic materials and the like, and good insulating property and impact resistance are provided; the soft filler may be various types of silicone, thermoplastic polyurethane elastomer rubber, or other flexible materials, which is not limited in the present invention.

The flexible pulse generator 100 further comprises an electrical pulse generation module enclosed within the flexible housing, the electrical pulse generation module being configured as a flexible structure that does not impede bending deformation of the flexible housing. With reference to fig. 6, the electric pulse generating module includes an inductor 121, a flexible battery 122, and a flexible circuit board 123. The inductor 121 is connected to the flexible battery 122, and the flexible battery 122 is connected to the flexible circuit board 123. The sensor 121 is configured to wirelessly communicate with the outside to receive an external control signal, and the flexible battery 122 and the flexible circuit board 123 are configured to jointly generate an electrical pulse according to the control signal. Specifically, after the inductor 121 receives an external control signal, the flexible battery 122 supplies power to the flexible circuit board 123, a signal processing circuit is etched on the flexible circuit board 123, the signal processing circuit includes an amplifying circuit and a waveform conversion circuit, an input end of the amplifying circuit is connected with the flexible battery 122, an output end of the amplifying circuit is connected with an input end of the waveform conversion circuit, and an output end of the waveform conversion circuit is used for being connected with the electrode 200. The electric energy output by the flexible battery 122 is processed by the amplifying circuit and the waveform converting circuit and then converted into electric pulses, and further transmitted to the electrode 200, and then acted on a target point by the electrode 200.

Further, the flexible battery 122 is a rechargeable battery, and the inductor 121 is further configured to charge the flexible battery 122. In this embodiment, the inductor 121 is preferably an induction coil, and the flexible battery 122 is a flexible energy storage device in which an organic material electronic component and/or an inorganic material electronic component is fabricated on a flexible or ductile plastic or thin metal substrate, and is composed of a flexible electrode, a Gel Polymer Electrolyte (GPE), a diaphragm, and an encapsulation material, and has overall flexibility and ductility. The specific manufacturing method of the flexible battery 122 can be known to those skilled in the art, and is not described herein. In addition, the flexible circuit board 123 can be made of polyimide or polyester film, has the characteristics of high integration level, light weight, thin thickness, good bending property and strong reliability, and perfectly meets the requirements of the pulse generator.

The flexible pulse generator 100 is fixed on the skull according to the requirement, and the fixing mode is not limited by the invention. Referring to fig. 5, in this embodiment, at least one first fixing device is disposed on the flexible housing, and the number of the first fixing devices may be one or more, for example, the number of the first fixing devices is two, and the two first fixing devices are symmetrically disposed on the flexible housing. In an alternative implementation, the first fixing means comprises an extension arm 114, the extension arm 114 extending from the sidewall 113 radially outward of the flexible housing. The extension arms 114 are arranged in pairs, i.e., one extension arm includes an upper arm 114a and a lower arm 114 b. The distance between the upper arm 114a and the lower arm 114b gradually decreases in a direction away from the flexible housing, i.e., the upper arm 114a and the lower arm 114b approach each other in a radially outward extension. In a preferred embodiment, the flexible pulse generator has ends of the upper arm 114a and the lower arm 114b abutting each other in the non-implanted state. The flexible housing has a central axis, and the two extension arms 114 are symmetrically disposed on both sides of the central axis. When implanted, the extension arm 114 may be fixed to the skull bone by screws to secure the flexible pulse generator 100 to the skull bone. In other embodiments, the first securing means may be three or more, spaced around the circumference of the flexible casing, and may be of any shape.

Referring further to fig. 5, at least one electrode interface 115 is disposed on the sidewall 113 of the flexible housing for connecting with the electrode 200. The number of the electrode interfaces 115 may be one or two or more, and a plurality of the electrode interfaces 115 are arranged between the two first fixing devices along the circumferential direction of the flexible housing, and are preferably symmetrically disposed on both sides of the central axis. In this embodiment, the number of the electrode interfaces 115 is preferably four, so that the flexible pulse generator can be connected to one, two or more electrodes 200 at the same time, and a set of system can be used to meet the requirement of a doctor on simultaneous stimulation of four target points of the left and right brains of a patient, so that a plurality of sets of systems do not need to be implanted, the operation difficulty and risk are reduced, and the trauma to the patient is also reduced. In addition, when the electrode 200 is not connected to a part of the electrode interface 115, the vacant electrode interface 115 may be sealed by a sealing plug. Preferably, a waterproof structure is disposed at the electrode interface 115 to prevent liquid from entering the interior of the flexible pulse generator 100 and causing short circuit or contact problems. The implementation manner of the waterproof structure is not limited in the present invention, and for example, an annular silicon rubber ring 116 may be disposed inside the electrode interface 115, so that the electrode 200 forms an interference fit when inserted into the electrode interface 115 (as shown in fig. 7).

In addition, the medical device may also include an external device for transmitting the control signal to the flexible pulse generator 100 and transmitting relay energy to charge the flexible battery 122. The external device may include a radio frequency transmitter for transmitting the control signal to the inductor 121 and a power transmitter for converting power into relay energy, which is electromagnetic energy in this embodiment, and transmitting the relay energy to the inductor 121.

Next, referring to fig. 8, fig. 8 shows a schematic structural diagram of the electrode 200 in a preferred embodiment, in which the lower left corner of the diagram shows an enlarged view of the electrode 200 in the area a, and the upper right corner of the diagram shows an enlarged view of the electrode 200 in the area B. As shown in fig. 8, the electrode 200 includes a distal electrode portion 210, a middle section 220, and a proximal electrode portion 230 connected in series. The distal electrode portion 210 may include a directional electrode contact 211 for extending into brain tissue for electrical stimulation, and a visualization element 212, such as a visualization ring, for determining the circumferential position of the directional electrode contact 211 after surgery, facilitating the physician to confirm the contact used and perform electrical stimulation treatment on the patient. The middle section 220 may include a spiral wire (not shown) and a guide wire 221, and the structure of the middle section may be conventional and will not be described in detail. Preferably, the middle section 220 forms a helical coiled configuration to facilitate implantation. The proximal electrode section 230 is directly connected to the flexible pulse generator 100 (i.e., inserted into the electrode interface 115). Optionally, the proximal electrode portion 230 includes a fixation ring 231 and an electrode connection contact 232.

Referring back to fig. 5, at least one electrode interface 115 is disposed on the flexible housing of the flexible pulse generator 100. As such, at least one of the electrodes 200 may be included in a medical system, and when the medical system includes a plurality of the electrodes 200, the plurality of electrodes 200 are inserted into one of the electrode interfaces 115, respectively, such that the plurality of electrodes 200 are spaced apart to apply the electrical pulses to a plurality of target locations of a target tissue. Optionally, the electrodes 200 are one, two, three or four. Given the four electrodes 200, the convenience of using one set of the medical system meets the needs of both the physician and the patient for four simultaneous poles at the target site in the brain.

Further, the medical system further comprises a second fixation means for fixing the electrode 200 to the skull. For example, the distal electrode portion 210 of the electrode 200 is placed at a predetermined target treatment region of the patient, and the electrode 200 is fixed to the surface of the skull bone by the second fixing means. As shown in FIG. 9, the second fixation device may comprise a skull lock 300, and the skull lock 300 may adopt an existing skull lock structure and will not be described in detail. Further, one of the skull locks 300 may clamp one or more of the electrodes 200 simultaneously, for example, clamping two of the electrodes 200 simultaneously, to meet the needs of some users for Gpi (the medial aspect of the globus pallidus) and STN (the subthalamic nucleus) simultaneous stimulation.

Although the present invention is disclosed above, it is not limited thereto. Various modifications and alterations of this invention may be made by those skilled in the art without departing from the spirit and scope of this invention. Thus, if such modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include such modifications and variations.

Claims (11)

1. A medical device comprising a flexible pulse generator for generating electrical pulses;

the flexible pulse generator comprises a flexible shell, wherein the flexible shell comprises a bottom wall and a top wall which are oppositely arranged, and a side wall which connects the bottom wall and the top wall; the bottom wall and the top wall are same in shape and are coaxially arranged, and the area of the bottom wall is larger than that of the top wall; the outer surface of the side wall is in a curved surface shape protruding outwards.

2. The medical device of claim 1, wherein the flexible pulse generator further comprises a pulse generation module enclosed within the flexible housing, the pulse generation module comprising an inductor, a flexible battery, and a flexible circuit board, the inductor being connected to the flexible battery, the flexible battery being connected to the flexible circuit board; the inductor is used for carrying out wireless communication with the outside so as to receive an external control signal, and the flexible battery and the flexible circuit board are used for generating the electric pulse together according to the control signal.

3. The medical device of claim 2, wherein the flexible battery is a rechargeable battery, and the sensor is further configured to receive externally relayed energy to recharge the flexible battery.

4. The medical device of claim 1, wherein the bottom wall and the top wall are both circular.

5. The medical device of claim 4, wherein the flexible housing is provided with at least one securing means for securing the flexible pulse generator to a predetermined object.

6. The medical device of claim 5, wherein the number of said fixation devices is two, two of said fixation devices being symmetrically disposed on said flexible housing.

7. The medical device of claim 5 or 6, wherein the securing means comprises an extension arm extending radially outward of the flexible pulse generator from a sidewall of the flexible housing.

8. The medical device of claim 1, wherein the sidewall has at least one electrode port disposed thereon for connection to an electrode.

9. The medical device of claim 8, wherein a waterproof structure is provided at the electrode interface.

10. The medical device of claim 7, wherein the extension arm includes an upper arm and a lower arm, the distance between the upper and lower arms gradually decreasing in a direction away from the flexible housing.

11. A medical system comprising an electrode and a medical device according to any of claims 1-10, the electrode being connected to the pulse generator for applying the electrical pulse to target tissue.

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