CN110064131A - A kind of controllable wireless heart pacemaker system and production method of multi-electrode pace-making - Google Patents

Abstract

The invention discloses a multi-electrode pacing adjustable wireless cardiac pacemaker system and a manufacturing method. The wireless pacemaker system includes a closed casing, and a plurality of fixing hooks are arranged on the casing and are arranged between the fixing hooks. There are at least one or more stimulating electrodes and a plurality of pacing and sensing channel modules arranged in the housing, and a battery. The pacemaker system has the function of electrode "compensation". When a single electrode fails, another electrode can be controlled and exchanged for pacing outside the body without a second operation. In addition, the pacemaker system can remotely control the number of electrodes used according to the actual clinical situation of the patient. The system of the invention increases the probability of the electrode target contacting the myocardium, reduces the risk of perforation when the pacemaker is implanted, reduces the number of re-implantation of patients with myocardial necrosis, prolongs the service life of the implanted device, and the stimulation intensity can also be adjusted. It varies from patient to patient, and it has great reference and application value for active implantable devices.

Description

A multi-electrode pacing adjustable wireless cardiac pacemaker system and manufacturing method

technical field

The invention belongs to the field of medical devices, and in particular relates to an implantable multi-electrode pacing wireless cardiac pacemaker system that can be regulated in vitro.

Background technique

A pacemaker is an electronic device implanted in a patient's body that emits electrical pulses through a pulse generator and conducts through wire electrodes to stimulate the myocardium to excite and contract the heart. Nearly 250,000 pacemakers are implanted in China every year, and 700,000 pacemakers are implanted worldwide. With the continuous research and development of the molding process, the pacemaker has developed from a wired to a wireless pacemaker, and has been miniaturized from a volume of 9.7cm ³ to 0.8cm ³ .

Lead-related complications such as lead dislocation, infection, perforation, and lead breakage in lead-wired pacemakers frequently occur. And due to the large volume of the pacemaker with lead, it is buried in the subcutaneous layer to form a pocket, and the pocket bleeding is inevitable. Although the miniaturized wireless pacemaker is small in size, it has only one pacing electrode. When the myocardial necrosis at the implantation site cannot be used for pacing, the patient needs to be implanted in a second position, which increases the operation time and the probability of myocardial perforation.

The wireless cardiac pacemaker system invented by this patent has multiple pacing electrodes, which not only avoids various complications caused by large wires and large volumes, but also can be replaced in vitro when myocardial necrosis occurs at a certain electrode implantation position. One electrode pacing greatly improves the success rate of one implantation and reduces the probability of myocardial perforation.

In this paper, several relevant documents and patents were found by searching Google, Pubmed, and Chinese patent publication announcements. The differences are as follows: In 2012, Medtronic issued patent 2012/0172690 A1, which announced a new type of wireless cardiac pacemaker with small size. The difference from the present invention is that it has only one pacing electrode and cannot realize the exchange function; CN 202490331 U A multi-electrode wireless cardiac pacemaker, the patent is a utility model and discloses a multi-electrode for simultaneous pacing of the atrium and the ventricle Pacemaker system. Unlike the present invention, it only implants multiple electrodes into the inner or outer wall of the heart, not the pacemaker itself.

SUMMARY OF THE INVENTION

The invention provides an implantable multi-electrode pacing wireless cardiac pacemaker system that can be controlled externally. The wireless pacemaker system mainly includes a battery, a plurality of pacing and sensing channel modules, and a plurality of fixing hooks. , a plurality of electrodes, a housing portion encasing the battery circuit, and an external controller in communication with the sensing channel module, where the pacing electrodes are located over the securing hooks.

The number of the fixing hooks is 3 or 4, and is made of a material with shape memory properties, which can be a nickel-titanium alloy.

The electrode is located at the beginning of the arc of the fixed hook. During the delivery process, the fixed hook is opened to maintain maximum elasticity. After the elasticity is completely released, the fixed hook is inserted into the myocardial tissue for fixation, and the electrode is located inside the myocardial tissue. The pacing electrode is spherically penetrated on the fixed hook, and the spherical electrode surface can achieve a uniform stimulation effect. An insulating silicone pad is arranged between the pacing electrode and the fixing hook.

The extracorporeal controller includes two control units, one control unit is configured to communicate with the in vivo wireless pacemaker system and the other control unit is configured to control the pacing pulse pathway according to the information transmitted by the first control unit. For example, when the patient's clinical condition requires pacing with two electrode strengths, the second control unit opens a second channel where both pulses are delivered simultaneously.

The described wireless pacemaker system, when the sensing module cannot sense a certain electrode pacing signal (myocardial necrosis at the implantation site), it can be remotely switched to the electrode in the effective position for normal pacing, thus the pacemaker system has the " The "electrode switching" function can reduce the probability of myocardial perforation; in addition, the number and intensity of pacing electrodes can be adjusted externally according to the actual clinical needs of the patient, and any one electrode can be controlled externally for pacing, or any two electrodes can be paced or Any three-electrode pacing can even achieve four-electrode pacing at the same time.

The advantages of the present invention are that multiple electrodes are lead-free pacing, which not only solves the problems of fatigue, dislocation, infection, breakage and the like caused by leads of the wired pacemaker, but also reduces the risk of myocardial perforation for single-electrode wireless pacing.

Description of drawings

Figure 1 is a schematic diagram of the location of the underlying heart with the implanted device.

Figure 2 is a schematic diagram of the appearance of a multi-electrode adjustable wireless cardiac pacemaker.

Figure 3 is a schematic diagram of the interconnection of wireless pacemaker components.

Figure 4a shows the pulse channels corresponding to different numbers of electrodes.

Figure 4b is a schematic diagram of selected in vitro control of combined electrodes.

Figure 5. Side view of the wireless pacemaker fixing hook.

Figure 6 Schematic diagram of the cross-section of the fixing hook.

FIG. 7 is a schematic diagram of the state after the fixation hook with electrodes has penetrated into the endocardium of the heart.

Detailed ways

The techniques described herein can be applied to any electrode stimulation medical device, such as gastric stimulators, cardiac defibrillators, brain pacemakers, deep brain stimulators, subcutaneous neurostimulators, and other forms of stimulators. Embodiments are described in detail below according to the diagrams:

Please refer to Figure 1, which is a schematic diagram of the location of the potential heart of the implanted device. The wireless cardiac pacemaker 10 is implanted in the right ventricle 11 through the tricuspid valve through the right atrium 13 through a special transmission device at the myocardial position shown in (a). If the clinical situation occurs: the patient at the implantation site suffers from myocardial necrosis and myocardial scabbing as shown in the dotted circle in Figure 1(b), electrodes 2, 3, and 4 will not work, but do not need to be re-implanted at this time , the No. 1 electrode can play a pacing effect.

The schematic diagram of the multi-electrode wireless cardiac pacemaker of the present invention is shown in FIG. 2 , and the schematic diagram of the interconnection of the components of the wireless pacemaker is shown in FIG. 3 . The implantable wireless cardiac pacemaker 10 includes a housing 30, a battery 15, an electrical circuit 16, a hook-shaped fixing member 17, and an electrode 18 mounted on the fixing hook. An insulating silicone pad can be arranged between the electrode 18 and the fixing member 17 . The material of the fixed part 17 can be a nickel-titanium alloy with shape memory function and high elasticity, and anti-inflammatory drugs can be coated on the surface of the fixed part 17 to prevent myocardial inflammation caused by prolonged friction. The material of the electrode 18 can be made of TiN substrate with an oxide coating. The shape of the electrode 18 is like a mushroom head and is hung on the implanted device. Stimulate.

Figure 4a shows the pulse channels corresponding to different numbers of electrodes, and Figure 4b is a schematic diagram of the electrode selection in vitro control. The selection of the pulse channel is based on the sensing module to determine the clinical needs of the patient, and is realized by the in vitro controller. E0 represents anode, E1, E2, E3, E4 represent cathode. Pulse channel 2 is turned on when two combined electrodes stimulate pacing, and pulse channel 3 is turned on when three combined electrodes stimulate and pacing. The pulse width and time period can be adjusted by an external controller.

The specific implementation details of the electrode 18 and the fixing part 17 are shown in FIG. 5 , which is a side view of the fixing part of the wireless cardiac pacemaker, including the bending angle 20 of the hook and the extension length 21 of the hook. The end is made into an arc shape to reduce the force area and increase the insertion force. The design of the curved shape of the fixing member can be multi-standard, and the patient's myocardial tissue must be penetrated in the process of releasing the elasticity. For this reason, the length 21 must be large enough to overcome the elasticity of the myocardial tissue, and the bending angle 20 must also ensure that the hook reaches A certain elasticity ensures that the hook penetrates smoothly after piercing the myocardial tissue. The bending angle 20 can be set at 160° ^. to 180 ^. In between, the bending radius is set between 1.7mm and 2.0mm, and the length 21 is set between 3.7mm and 4.0mm.

The fixing hook 17 is set to a certain radian according to the requirement of force, and the cross section at one end near the pacemaker is designed as an ellipse, and there are two circular holes 25 of the same size, as shown in the schematic cross-sectional view of the fixing hook in FIG. 6 . The purpose is that the lead wire is led out from the circuit and connected to the electrode 16 through the round hole 25 in the fixing hook. Two round holes lead out two leads, reducing the risk of electrode failure.

The electrode 18 is installed at about the bottommost position where the fixing hook 17 is bent. After the fixing hook is completely released and elastically fixed to the myocardium, the electrode 18 is just located inside the myocardial tissue 19, and the state after the fixing hook with the electrode 18 has penetrated into the endocardium of the heart Schematic 7.

Claims (8)

1. a kind of controllable wireless heart pacemaker system of multi-electrode pace-making, comprising:

Sealing shell, the interior shell includes battery, multiple pace-makings and induction channels module；

Multiple stay hooks of one end outside shell are set；

One or more pacing electrodes on stay hook are set, for stimulating endomyocardial and transmitting to external control device Inductive signal；

The steroids repository of the fixed one end of shell is set；

External controller.

2. a kind of controllable wireless heart pacemaker system of multi-electrode pace-making as claimed in claim 1, it is characterised in that: The multiple pacing electrode is separately positioned on the stay hook.

3. a kind of controllable wireless heart pacemaker system of multi-electrode pace-making as claimed in claim 1, it is characterised in that: Multiple pace-makings and induction channels module in the shell respectively correspond the multiple pacing electrode.

4. a kind of controllable wireless heart pacemaker system of multi-electrode pace-making as claimed in claim 1, it is characterised in that: The stay hook is heat-treating profiled using Nitinol, has high resiliency.

5. the controllable wireless heart pacemaker system of multi-electrode pace-making as claimed in claim 2, it is characterised in that: the electricity Medical silica-gel felt pad is set between pole and the stay hook.

6. induction channels module as claimed in claim 1, it is characterised in that: can incude and feed back and (feed back to external control Device) implanted device some electrode pacing signal.

7. external controller as claimed in claim 1, it is characterised in that: there are two control unit, a control unit quilts It is set as communicate with internal wireless pacemaker system, what another control unit was arranged to be transmitted according to first control unit Information controls pacemaker impulse access.

8. a kind of controllable wireless heart pacemaker system of multi-electrode pace-making as claimed in claim 1, which is characterized in that Multiple pace-makings and induction channels module are in communication with each other with external controller, can be according to patient's actual clinical need of induction It asks, the external quantity and intensity for adjusting pacing electrode, any one electrode pace-making can be controlled in vitro or any two electrode rises It fights or any three electrodes pace-making can even accomplish while four electrodes pace-makings.