Design, Development and Evaluation of Medical Devices

Design, Development and Evaluation of Medical Devices

We address clinical needs and gap in market to produce reliable and accurate physiological and clinical data to inform treatments. The founders have co-invented several medical devices to obtain reliable and accurate clinical data to inform treatment plans and improve and quality of life.

The First Ray Mobility and Position Device (MAP1st)

Excessive or insufficient 1st ray mobility (FRM) is associated with numerous painful, disabling, and limb threatening pathologies, including hallux valgus1–4,8,12-16, hallux rigidus1,4,5,6,7, osteoarthrisis of the tarsometatarsal joint1,7, metatarsalgia9, diabetic foot ulceration10,11, pes cavus1, and pes planus1. Reliable measures of FRM can inform clinical and surgical decisions. In the absence of commercially available clinical instruments for FRM measurement, unreliable manual methods are employed to estimate FRM (Fig. 1). Clinicians could build treatment algorithms if a reliable, user-friendly commercially available was available.

To address this clinical gap, we designed, developed and evaluated the MAP1st device (Fig. 2), a reliable user-friendly equipment for FRM measurement and better clinical diagnostics and informed treatment. MAP1st provides reliable measures of 1st ray mobility & position wirelessly (Fig. 3) in ≤1 minute on patients with foot pathologies, including Hallux Rigidus, Hallux Limitus, Hallux Rigidus, Metatarsalgia, Flatfoot, Diabetic Neuropathic Ulceration, and Plantar Fasciitis. The data can be saved pre- and post-intervention and accessed securely, allowing informed and efficient clinical treatment and improved patient care.

Figure 1: The problem

Figure 2: The solution

Fast data acquisition

Figure 4: Secure and efficient record keeping

The Arch Height Index (AHI) device gives reliable measures AHI and arch height flexibility bilaterally.

The Arch Height Index Device (AHI)

Foot structures, such as arch height, have been linked to pathologies, such as repetitive injuries, hammer toes, and bunions.  We developed the Arch Height Index (AHI) device to obtain reliable and accurate measures of arch height to understand relationships between foot structure and foot function, and to inform treatment plans.

Foot structure measures, such as arch height index and arch height flexibility, can be computed from measured values of arch height during standing and sitting, total foot length and body weight.

The Arch Height Index (AHI) device gives reliable measures AHI and arch height flexibility bilaterally.

Zifchock RA, Theriot C, Hillstrom HJ, Song J, Neary M. The Relationship Between Arch Height and Arch Flexibility(A Proposed Arch Flexibility Classification System for the Description of Multidimensional Foot Structure). J Am Podiatr Med Assoc. 2017 Mar;107(2):119-123.

Drefus LC, Kedem P, Mangan SM, Scher DM, Hillstrom HJ. Reliability of the Arch Height Index as a Measure of Foot Structure in Children. Pediatr Phys Ther. 2017 Jan;29(1):83-88.

Butler RJ, Hillstrom H, Song J, Richards CJ, Davis IS. Arch height index measurement system: establishment of reliability and normative values. J Am Podiatr Med Assoc. 2008 Mar-Apr;98(2):102-6.

Zifchock RA, Davis I, Hillstrom H, Song J. The effect of gender, age, and lateral dominance on arch height and arch stiffness. Foot Ankle Int. 2006 May;27(5):367-72.

The First Metatarsophalangeal Joint Flexibility Device

The first metatarsophalangeal joint has been linked with osteoarthritis, thereby warranting reliable and accurate measure of joint flexibility. We developed the First Metatarsal Phalangeal Joint Flexibility (1stMTPJflexibility) device to obtain reliable measures of 1stMTPJflexibility bilaterally in adults. This information is used to understand relationships between foot structure and foot function, and to inform treatment plans.

First Metatarsal Phalangeal Joint Flexibility (1stMTPJflexibility): an electromechanical device (right) that reliably measures 1stMTPJflexibility bilaterally in adults

Cody EA, Kraszewski AP, Marinescu A, Kunas GC, Mani SB, Rao S, Hillstrom HH, Ellis SJ., Measuring Joint Flexibility in Hallux Rigidus Using a Novel Flexibility Jig. Foot Ankle Int. 2017 Aug;38(8):885-892. doi: 10.1177/1071100717709538. Epub 2017 May 23.Foot Ankle Int. 2017. PMID: 28535691

The Arch Height Index (AHI) device gives reliable measures AHI and arch height flexibility bilaterally.

First Metatarsal Phalangeal Joint Flexibility (1stMTPJflexibility): an electromechanical device (right) that reliably measures 1stMTPJflexibility bilaterally in adults

Co-inventors: Howard Hillstrom, Jinsup Song

Cody EA, Kraszewski AP, Marinescu A, Kunas GC, Mani SB, Rao S, Hillstrom HH, Ellis SJ. Measuring Joint Flexibility in Hallux Rigidus Using a Novel Flexibility Jig. Foot Ankle Int. 2017 Aug;38(8):885-892.

Rao S, Song J, Kraszewski A, Backus S, Ellis SJ, Deland JT, Hillstrom HJ. The effect of foot structure on 1st metatarsophalangeal joint flexibility and hallucal loading. Gait Posture. 2011 May;34(1):131-7. doi: 10.1016/j.gaitpost.2011.02.028. Epub 2011 May 1.

Power tool control systems for surgical application

Orthopedic surgical procedures often involve bone machining. However, bones cells may be damaged when exposed to temperatures higher than 55°C, and this could lead to implant failure. To address this problem, we developed an intelligent medical power tool which regulates both oscillations and drilling speed to prevent a rise in temperature and associated potential thermal damage to the bone.

https://patents.google.com/patent/WO2007141578A2/zh

Co-inventors: Claudio Zizzo, Rajshree Hillstrom (Mootanah)

An Intermittent Pneumatic Graduated Compression Boot for the Treatment of Venous Ulcers

Venous ulcers are open lesions of the lower limb, difficult to manage, expensive to treat, often recurs, and are most prevalent among seniors with concomitant chronic venous insufficiency. The incidence rate is up to 1.33% and 60% of venous leg ulcers result in a chronic wound.

We designed, developed and tested a prototype intermittent pneumatic graduated compressive boot for the treatment of venous ulcers. The device comprises a microcomputer-based controller that regulates the magnitude and frequency of airflow in and out of the cuffs to improve circulation. A customized software and mobile app were developed to control the air pressure at different locations of the foot wirelessly. Significant augmentation of blood flow in the popliteal vein, following the compression cycle, was recorded by a miniature flat 8 MHz Doppler probe. The device could provide accessible, versatile and patient-specific treatment for venous ulcers.

Prototype intermittent pneumatic compression boot.

Waveform patterns in the reservoir, proximal, mid and distal air chambers and the resulting changes of the popliteal vein flow show good response to dynamic compression (Doppler signal readings).

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