早先的起搏器由于存在诸多问题，限制其临床广泛应用，例如需开胸植入起搏导线电极，起搏阈值很快升高，导线容易折断、移位，电池寿命较短和稳定性差。为解决上述问题，不少学者和工程师做了不懈的研究。

全球心脏起搏器植入手术的数量

公开/公告号	US8129622B2	申请日	2009-05-21
发明名称	Insulator for feedthrough
解决的技术问题	Construction of a feedthrough assembly can require the use of forming weights, complicating production, and in some instances, limiting the minimum feedthrough size. In addition, some insulating members are susceptible to reaction with aqueous solutions, such as body fluids. Reaction with body fluids can erode the insulating member and diminish performance over time. It is desirable to develop improved feedthroughs for IMDs.
技术方案	A hermetically sealed microelectromechanical system (MEMS) package for an implantable medical device is presented. The MEMS comprises a first substrate that includes an aperture. A feedthrough assembly is coupled to the aperture; the feedthrough assembly comprises a conductive element housed in a glass insulati ng member. A second substrate is coupled to the first substrate.
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雅培Aveir是一款具有独特映射功能的无导线起搏器，可在放置前评估正确定位。Aveir无引线起搏器旨在提供心动过缓起搏，作为脉冲发生器，内置电池和电极，用于植入右心室，为目标患者群体提供内在心脏信号的感测和心脏起搏治疗。而且该产品的预计电池寿命比其他目前市售的无引线起搏器长两倍。

重点专利  

对于AVEIR起搏器，雅培对其进行了细致性的专利布局，笔者从涉及的相关专利中分别择机选择了2组(原理和输送系统)专利进行了解析，相关结果如下：

1

公开/公告号	US8295939B2	申请日	2011-05-17
发明名称	Programmer for biostimulator system
解决的技术问题	Known pulse generators can include various sensors for estimating metabolic demand, to enable an increase in pacing rate proportional and appropriate for the level of exercise. The function is usually known as rate-responsive pacing. For example, an accelerometer can measure body motion and indicate activity level. A pressure transducer in the heart can sense the timing between opening and closing of various cardiac valves, or can give a measure of intracardiac pressure directly, both of which change with changing stroke volume. Stroke volume increases with increased activity level. A temperature sensor can detect changes in a patient’s blood temperature, which varies based on activity level. The pacemaker can increase rate proportional to a detected increase in activity.
技术方案	A biostimulator system comprises one or more implantable devices and an external programmer configured for communicating with the implantable device or devices via bidirectional communication pathways comprising a receiving pathway that decodes information encoded on stimulation pulses generated by ones of the implantable device or devices and conducted through body tissue to the external programmer.
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2

公开/公告号	US8958892B2	申请日	2013-11-19
发明名称	Delivery catheter systems and methods
解决的技术问题	Although more than one hundred thousand conventional cardiac pacing systems are implanted annually, various well-known difficulties exist, of which a few will be cited. For example, a pulse generator, when located subcutaneously, presents a bulge in the skin that patients can find unsightly, unpleasant, or irritating, and which patients can subconsciously or obsessively manipulate or “twiddle”. Even without persistent manipulation, subcutaneous pulse generators can exhibit erosion, extrusion, infection, and disconnection, insulation damage, or conductor breakage at the wire leads. Although sub-muscular or abdominal placement can address some concerns, such placement involves a more difficult surgical procedure for implantation and adjustment, which can prolong patient recovery.
技术方案	A delivery system for implanting a leadless cardiac pacemaker into a patient is provided. The cardiac pacemaker can include a docking or delivery feature having a through-hole disposed on or near a proximal end of the pacemaker for attachment to the delivery system. In some embodiments, the delivery catheter can include first and second tethers configured to engage the delivery feature of the pacemaker. The tethers, when partially aligned, can have a cross-sectional diameter larger than the through-hole of the delivery feature, and when un-aligned, can have a cross-sectional diameter smaller than the through-hole of the delivery feature. Methods of delivering the leadless cardiac pacemaker with the delivery system are also provided.
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目前，对于心脏起搏器设备而言，依然以美敦力、雅培、波科等国外企业为主，不过随着国内重视程度不断提高的情况下，中国公司蓄势待发，在一片被普遍看好的市场中开始暗流涌动，虽然目前真正的国产心脏起搏器成品问世很少，但是随着各个“卡脖子”技术不断攻克，国产心脏起搏器一定会在近几年实现重大突破和问世。

目前，国内各大心脏起搏器领域医疗厂商还会将美敦力、雅培、波科等重要竞品作为标杆和对照，但是随着各大国内厂商联动产学研医生多方力量，不断创新，必将推动中国心脏起搏器业更智能化、精准化、便携化的发展，也会逐步摆脱国外竞品带来的压力和技术障碍，不过，国外巨头公司和国内新兴企业在知识产权方面布局更加紧密，心脏起搏器赛道上的各个国内厂商之间的竞争也会逐渐激烈，届时相关知识产权问题也必将会成为各大心脏起搏器厂商的研究重点课题，后续相关产品的的研发和专利事务值得持续关注。

苏州医疗器械展Medtec China已经从2012年开始连续举办了7届植入介入医疗器械峰会，会议围绕骨科植入物、心血管介入产品，探讨其法规政策、市场趋势、研发与设计与材料创新等内容，为医疗器械制造商、材料供应商及服务商等提供国内外的经验借鉴。今年作为苏州医疗器械展Medtec China同期“植入介入医疗器械峰会”的第八个年头，会议内容再次升级，高校、医院、企业的嘉宾讲从材料、临床需求、产品研发等多维度剖析植入介入现状及发展。点击快速预登记。

参考资料：医械知识产权、朱晓晓心电资讯、 微创心律招股书等。医械知识产权撰写成文，享有本文劳动成果，转载务必注明出自医械知识产权。