Invented by Michael S. Rosenberg, Mark R. Christianson, Interrad Medical Inc

The market for systems and methods for anchoring medical devices has been steadily growing in recent years. As the demand for minimally invasive procedures and surgical interventions continues to rise, the need for reliable and effective anchoring solutions has become paramount. Anchoring medical devices is a critical step in many procedures, as it ensures that the device remains securely in place throughout the treatment or surgery. Whether it is a catheter, stent, pacemaker, or any other medical device, proper anchoring is essential for successful outcomes. One of the key drivers of this market is the increasing prevalence of chronic diseases and the aging population. With a growing number of individuals requiring long-term medical interventions, the demand for anchoring systems and methods has surged. For instance, the rising incidence of cardiovascular diseases has led to a higher demand for anchoring solutions for cardiac devices such as pacemakers and defibrillators. Furthermore, technological advancements have played a significant role in the expansion of this market. Innovations in materials, design, and manufacturing processes have led to the development of more efficient and reliable anchoring systems. For example, the introduction of bioabsorbable materials has revolutionized the field by providing temporary anchoring solutions that gradually dissolve within the body, reducing the risk of complications. Another factor contributing to the growth of this market is the increasing adoption of minimally invasive procedures. These procedures offer numerous benefits such as reduced scarring, shorter recovery times, and lower risk of infection. However, they also require specialized anchoring systems that can securely hold the medical device in place without causing damage to surrounding tissues. As a result, there is a growing demand for innovative anchoring solutions that are specifically designed for minimally invasive procedures. The market for systems and methods for anchoring medical devices is highly competitive, with numerous players vying for market share. Key industry players include medical device manufacturers, research institutions, and academic centers. These entities are constantly investing in research and development to introduce new and improved anchoring solutions. Geographically, North America dominates the market due to the presence of a well-established healthcare infrastructure and a high prevalence of chronic diseases. However, the Asia-Pacific region is expected to witness significant growth in the coming years. Factors such as a large population base, rising healthcare expenditure, and increasing awareness about advanced medical treatments are driving the demand for anchoring systems and methods in this region. In conclusion, the market for systems and methods for anchoring medical devices is experiencing steady growth due to factors such as the increasing prevalence of chronic diseases, technological advancements, and the rising adoption of minimally invasive procedures. As the demand for reliable and effective anchoring solutions continues to rise, the industry is expected to witness further advancements and innovations in the coming years.

The Interrad Medical Inc invention works as follows

Some embodiments of the medical device anchor system are anchor devices that hold a medical instrument in place (such as a cath or similar) relative to a point of skin penetration using subcutaneous anchors.

Background for Systems and Methods for Anchoring Medical Devices

Venous catheters, arterial catheters, and body liquid catheters are frequently used by doctors.” These catheters can be used for many purposes, including accessing the vascular system to perform dialysis or to introduce pharmaceutical agents. They may also be used for fluids and nutrition, hemodynamic monitoring and blood drawing. Catheters can also be used to drain fluid accumulations and treat infections. Catheters can also contain electrical leads to be used for neuro-stimulation or cardiac pacing. After the catheter has been introduced into the patient’s body, it is attached to the patient. The catheter is often secured to the skin of the patient by using adhesive tape or suturing the catheter hub. Other times, a subcutaneous anchor device (such as a sleeve with anchors and an actuator that is used to deploy them) may be used to secure the catheter. The medical practitioner may clean the area of skin around the catheter inserting site to improve the patient’s safety and comfort.

Some embodiments of the medical device anchor system comprise an anchor device which receives a surgical instrument (such a catheter, or similar instrument that may be equipped with suture wing) and secures it in place at a skin penetration site. The medical anchor device, for example, can be configured so that the suture wing hubs on a catheter are releasably coupled to the subcutaneous anchor mechanism deployed through the skin penetrating point already occupied by a catheter. This reduces or eliminates the need to install sutures through both the suture wing hubs and the patient’s own skin. In some embodiments, the anchor device may be folded in such a way that the subcutaneous anchor tines are aligned in a side-by-side arrangement to make insertion easier. This configuration allows the anchor to be attached after the medical instrument has been placed, without needing a second penetration for the anchor. The anchor device can be configured in certain embodiments to make it easier to use, more adaptable for use with different sized medical instruments, and to allow the skin tissue to be cleaned and maintained at the skin penetration point and surrounding the penetration point.

Some embodiments of the invention described herein include a device to secure the position of a surgical instrument. The anchor device can include a retainer and first and/or second anchors that extend from the retainer. The retainer body may include a pivotable first body part that is coupled to a secondary body part about a longitudinal folding axis. The retainer body can also include an anchor engagement portion that is designed to easily receive one or multiple apertures defined on a catheter hub. Optionally, the first and second anchors can extend distally out of a distal end. Each anchor can include a flexible pin that can be deployed in the subcutaneous area to secure a retainer body to a penetration. The first anchor can be coupled with the first body part and the second anchor can be coupled with the second body part. The first body part of the retainer can be pivotable with respect to the second about the longitudinal fold axis. This allows the first anchor to be adjusted from a configuration where the flexible tines face outwards away from each other to a configuration where the flexible pins face in the same general direction.

Specific embodiments of the invention described herein include a anchor device for locking a position of a surgical instrument. The anchor device can include a retainer having a first portion pivotably coupled with a second portion around a longitudinal fold-axis. The retainer may also have one or more anchor engagement parts that are configured to mate to an external structure of a surgical instrument in order to securely secure the instrument to the body. The anchor device can also include two anchors that extend from the distal end. Each anchor has a flexible tine which can be deployed in the subcutaneous area to secure the retention body relative to an penetration point. The first anchor can be coupled with the first body part, and the other anchor can be coupled with the second body part. The first body part of the retainer can pivot relative to the second about the longitudinal fold axis, so that the first anchor and the second anchor can be adjusted to go from a configuration where the flexible pins are pointing outwards away from each other to a configuration where the flexible pins are extending generally in the same directions.

Further embodiments of the present invention include a system to secure the position of a surgical instrument. The system can include an anchor device and an adapter. The adapter can include a hub section that is elastically flexible and designed to engage and surround the outer surface of a medical instrument. The adapter can also have a second part with one or more engagement elements extending outwards from the hub portion. The anchor device can include a retainer consisting of a first portion which is pivotably attached to a second portion. The anchor device can also include one of more anchor engagement parts that are configured to releaseably couple with one or more engagements members extending from the hub portion. The anchor device can also include first and second distal anchors that extend from the distal end. Each anchor can include a flexible time which is deployable into a subcutaneous area to secure the retainer body relative to a penetration. The first anchor can be coupled with the first body part, and the other anchor can be coupled with the second body part. The first body part of the retainer can be pivotable with respect to the second. This allows the first and the second anchors to be adjusted from each other to a removal configuration where the flexible tines extend in a general direction.

Other embodiments may include a kit containing components to secure the position of a cathode relative to a penetration site. The kit can include a sterile packaging containing one or more adapters with hub portions that have longitudinal lumens of different shapes or sizes. The sterile packaging may contain two or more adapters, each with a hub portion that has a longitudinal lumen of varying size and shape. Each of the two adapters included in the sterile packaging may also include one or more flanges that extend outwards from the hub portion. The hub portion can include a longitudinal cut through the wall portion that allows access to a respective longitudinal lumen. “The one or more flanges can each include an adapter engaging portion configured to engage releasably with retention posts of an Anchor Device.

Other embodiments may include a kit containing an anchor and a catheter in a sterile packaging. The anchor device may be a hub with one or more apertures. Anchor devices may have a retainer that includes a pivotable first body part and a second body part. The anchor device may include a retainer body with one or multiple anchor engagement portions that are designed to be releasably coupled with one or several catheter engagement portions located on the hub of a catheter. The anchor device can also include two anchors that are distal from the body. Each anchor can include a flexible time which is deployed in a subcutaneous area to secure the retainer body relative to a penetration. The first anchor can be coupled with the first body part, and the other anchor can be coupled with the second body part. The first body part of the retainer can be pivotable with respect to the second. This allows the first and the second anchors to be adjusted from each other to a removal configuration where the flexible tines extend in the same general direction.

Specific embodiments described herein can include a method for using a medical anchoring system.” The method can include advancing a medical anchor system toward a skin penetrating point, while it is folded. This will ensure that the subcutaneous tines are oriented in the same direction and generally adjacent. While the anchor device in folded state, the method can also include inserting subcutaneous tines into the subcutaneous region adjacent an underside of the skin layer through the skin penetrating point. The subcutaneous tines can have a shape, which may be curved or shaped in a particular way. This shape will terminate at the tip of the free end when inserted through the skin penetration. After the subcutaneous pins have been inserted, the anchor device may be adjusted to a nonfolded state so that the subcutaneous pins are in a position of anchored positioning where the free ends are generally separated from each other. After the subcutaneous tines have been adjusted in the subcutaneous area, the method can include attaching a medical device to the anchor. The anchor device may have one or multiple protrusions that extend from it. This can be coupled with the one or several apertures on the medical tool.

These and other embodiments can provide one or more advantages. Some embodiments of an Anchor System can hold a medical device in the desired position relative a skin penetration without having to use sutures or skin adherents. The anchor device can be easily adapted to work with different sizes of catheters and medical instruments. It also allows for a better inspection and cleaning of skin tissue around and at the skin penetration points. Some embodiments can be capless, where the anchor device is releasably coupled to an external portion on the catheter or medical instrument without a cap device. This simplifies the inspection and cleaning of the anchor and skin near the skin penetration site. In some embodiments, an anchor device can be adjusted from a folded to a non-folded position so that subcutaneous anchors extend in the same general direction when the device is installed through the skin penetration point and removed. In some embodiments, an anchor device can also be installed using a technique which reduces or eliminates any need to move the subcutaneous anchors’ tines into or out of a flexed, stressed configuration. In these embodiments, subcutaneous anchors can be easily installed and removed without the use of an external actuator or delivery system. In some embodiments the configuration of an anchor device simplifies the process of attaching a medical device to the anchor device. In some embodiments the anchor device is configured to work with different styles and sizes medical instruments. In some embodiments, an anchor device allows a hub or another medical instrument to be placed in close proximity to a skin penetration point.

The drawings and description below provide details about one or more embodiments. The description, drawings and claims will reveal other features, advantages and objects of the invention.

DESCRIPTION of Drawings

FIG. “FIG.

FIGS. “FIGS. 2A-2C show the anchor device in FIG. 1 from different perspectives, including a side view, a rear view, and angled views. 1 .

FIGS. “FIGS. “Figure 1 in a rolled condition, according to some embodiments.

FIGS. “FIGS. “1, for use in securing a position of a surgical instrument.

FIGS. “FIGS. “Figure 1 is a shaft lock accessory for use with the anchor device of FIG.

FIG. “FIG. The anchor device of FIG. 7A-7C in a deployed configuration.

FIG. “FIG.

FIG. “FIG. 10 shows a perspective of an anchoring system with an alternative embodiment.

Like reference symbols on the different drawings indicate like elements.

Referring to FIG. Some embodiments of the medical device anchor system 10 comprise an anchor device 100 which releasably holds a medical tool 20 in an operating position relative to a skin portion 30. The anchor device 100 can mechanically couple the medical instrument 20. The anchor device 100 can then be attached to the skin portion 30. The anchor device 100 acts as an intermediary to retain the medical instrument in the desired position relative to the skin 30. FIG. The example embodiment shown in FIG. The example embodiment of FIG.

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