The present disclosure is directed to an upper extremity prosthesis and more particularly, to an upper extremity prosthesis for use in below the elbow amputations with an osseointegration post, especially those with short residual limb lengths below the elbow.
Amputations are often classified as being either upper extremity amputations or lower extremity amputations.
There are many levels of upper extremity amputations, and with each one comes a different method of rehabilitation as well as a different type of prosthesis. For example, different levels of upper extremity amputations includes but are not limited to: (1) fingers or partial hand (transcarpal); (2) at the wrist (wrist disarticulation); (3) below the elbow (transradial); (4) at the elbow (elbow disarticulation); (5) above the elbow (transhumeral); (6) at the shoulder (shoulder disarticulation); and (7) above the shoulder (forequarter).
Similarly, there are many levels of lower extremity amputations, and with each one comes a different method of rehabilitation as well as a different type of prosthesis. For example, different levels of lower extremity amputations includes but are not limited to: (1) foot, including toes or partial foot; (2) at the ankle (ankle disarticulation); (3) below the knee (transtibial); (4) at the knee (knee disarticulation); (5) above the knee (transfemoral); and (6) at the hip (hip disarticulation.
A below elbow arm prosthetic is thus one which is located below the elbow and above the hand and is used after an upper extremity amputation is performed. An upper extremity amputation can result due to any number of conditions, including, but not limited to, severe trauma, blood vessel disorder (atherosclerosis), diabetes mellitus, malignancy, infection, congenital amputation, and gangrene. A below elbow (BE) or transradial prosthesis is custom made for a person who has had a BE or transradial amputation. The prosthesis generally consists of a custom-made socket, optional liner, wrist unit, and terminal device (e.g., a hand). Sometimes, the prosthesis can consist of a sleeve or other harness, depending on the suspension system used for that patient.
Osseointegration
Osseointegration is a blossoming field in the surgical space and generally, osseointegration is the scientific term for bone ingrowth into a metal implant. An artificial implant is permanently, surgically anchored and integrated onto bone, which then grows into the implant. Osseointegration is most commonly used in dental implants. It has been very successful in these uses for decades. Osseointegration limb replacement is a type of surgery in which a limb prosthesis is connected directly to the skeleton.
When dealing with below elbow amputations, the length of the residual limb may cause complications in terms of upper extremity prosthetic fitting, etc. The present disclosure is directed to overcoming this challenge and provide an improved solution for mounting a prosthetic limb for a below the elbow amputee.
In general, the prosthesis 100 (
As mentioned, in one implementation of the prosthesis 100, the prosthesis 100 is used in an osseointegration limb replacement surgical procedure. While
The inner components of the prosthesis 100 include an elongated member 110 that has a first end 112 and an opposing second end 114. The first end 112 can be considered to be a proximal end and the second end 114 can be considered to be distal end. The elongated member 110 can be in the form of a tube, such as an aluminum tube. The first end 112 is detachably coupled to a first connector 120 and this attachment defines an interface. It is at this interface, that the prosthesis can be removed (detached) such as at night. Additional details concerning this detachment aspect and the interface are described herein. The attachment mechanism between the first end 112 and the first connector 120 is preferably of a type that can be easily disengaged to allow the main part of the prosthesis 100 to be selectively removed (detached), while optionally allowing the first connector 120 to remain in place.
Any number of materials can be used to form the elongated member110 and in one embodiment, the elongated member 110 can be a metal tube and more preferably, the elongated member 110 is in the form of an aluminum alloy tube.
The first connector 120 has a first face (first/proximal end) 122 and an opposite second face (second/distal end) 124. The first end 112 of the elongated member 110 is coupled to the second face 124 of the first connector 120 in such a way that the first end 112 can be detached and removed from the first connector 120. For example, a quick release type mechanism can be implemented or other type of mechanism that allows for the removal of the elongated member 110.
In one embodiment, the first connector 120 is an adapter that has an adjustable body 123 that can be manipulated so as to clamp the first end 112 of the elongated member 110. The body 123 thus can be a clamp body that includes a slot 125 that partitions the body 123 into two halves. The second face 124 of the first connector 120 includes an opening into which the first end 112 of the elongated member 110 is received. The first connector 120 includes a fastener 129 that is received within the body 123 and serves to: (1) tighten the body 123 about the first end 112 of the elongated member 110 so as to capture the first end 112 and (2) loosen the body 123 about the first end 112 of the elongated member 110. In other words, the tightening of the body 123 causes the two halves of the body 123 to compress and tightening around the first end 112 of the elongated member 110 resulting in a friction fit being formed between the first end 112 and the body 123. In this manner, the elongated member 110 can be held in place. When, such as at night, it is time for the prosthesis to be removed from the residual limb 10, the fastener 129 is loosed to cause the split body 123 to open up allowing for removal of the elongated member 110 from the first connector 120.
It will be appreciated that the first end 112 of the elongated member 110 can be held using other techniques, such as the use of a quick connect. In quick connect mechanisms, the first end 112 would carry a first quick connect part and the second face 124 of the body 123 would carry a second quick connect part that mates with the first quick connect part to attach the two parts. Other techniques can be equally used.
In an osseointegration type implementation, the first connector 120 can be connected to a second connector 130 that comprises an osseointegration post that has a first end 132 that is fixedly attached (implanted) into the ulna (bone) and an opposite second end 134 that is coupled to the first connector 120. The interface and connection between the first connector 120 and the second connector 130 can be of a permanent type in that during the intended use of the prosthesis 100, the connection between the first connector 120 and the second connector 130 is meant to be maintained.
In one embodiment, the second connector 130 is in the form of an osseointegration dual taper post with outer threads at the exposed second end 134 (e.g., the post can include ½×20 threads). The osseointegration post can thus be a threaded titanium post. The first face of the first connector 120 can include a threaded opening that receives the threaded osseointegration post 130. The osseointegration post 130 is thus anchored into bone (ulna) and provides a support for the first connector 120 (adapter). As shown in
Thus, in the illustrated embodiment, the first and second connectors 120, 130 are intended to be fixedly attached to the bone of the patient, while the main prosthetic components including the forearm structure (shell) is intended to be easily detachable to permit removal as at night or for cleaning, servicing, etc.
It will also be appreciated that the first and second connectors 120, 130 can be combined into a single part that is configured to be implanted into the ulna and mate with the elongated member 110.
The inner components of the prosthesis 100 include a first support 140 and a second support 150 that are configured to provide a framework for attaching an outer prosthetic shell 200 to the inner components. As shown, the outer prosthetic shell 200 can be a forearm shell that surrounds the inner components of the system 100. The outer prosthetic shell 200 has a first end 202 and an opposing second end 204. The first end 202 can be a proximal end and the second end 204 can be a distal end. Like a human arm, the outer prosthetic shell 200 has a tapered construction with the proximal end having a greater width (diameter) than the distal end. As discussed herein, the second end 204 can be thought of as being a wrist end, while the first end 202 is the end closer to the residual limb 10.
In accordance with the present disclosure, the first support 140 and the second support 150 are positioned along the elongated member 110 and are locked in place. In other words, the first support 140 and second support 150 surround and are fixedly attached to the elongated member 110. Each of the first support 140 and the second support 150 can include a main opening 143, 153 which receives the elongated member 110. The elongated member 110 thus passes through the first support 140 and the second support 150; however, during use, the first and second supports 140, 150 are not permitted to freely travel along the length of the elongated member 110.
Each of the first support 140 and the second support 150 can be a disk-shaped (wheel-like) structure that is constructed to surround the elongated member 110 and is configured to mate with the outer prosthetic shell 200. Since the outer prosthetic shell 200 has a tapered construction, a peripheral side wall 142, 152 of the first support 140 and the second support 150, respectively, likewise has a tapered construction since as described herein, this peripheral side wall 142, 152 seats against the inner surface of the tapered outer prosthetic shell 200. In addition, since the first support 140 and the second support 150 are located at different axial locations along the elongated member 110, the widths (diameters) of the first support 140 and the second support 150 are different. More specifically, the first support 140 is located closer to the first end 112 of the elongated member (rod or shaft) 110 compared to the second support 150 and therefore, the first support 140 has a greater diameter (width) compared to the diameter of the second support 150. The distance between the first support 140 and the second support 150 can vary depending upon different parameters like the overall length of the prosthetic shell 200. As a result, a hollow interior space 155 is defined within the outer prosthetic shell 200 between the first support 140 and the second support 150.
As discussed herein, the first support 140 and the second support 150 provide support for the prosthetic shell 200 by providing anchoring points for attaching the prosthetic shell 200 to the two supports. For example, fasteners 170 can be used to couple the prosthetic shell 200 to the first support 140 and the second support 150. More particularly, one or more and preferably a plurality of fasteners 170 can be used to attach the prosthetic shell 200 to the first support 140 and the second support 150. The fasteners 170 can be in the form of screws or the like that pass through the outer prosthetic shell 200 and into one of the first support 140 and the second support 150. The outer prosthetic shell 200 can include through holes that are aligned with the first support 140 and the second support 150 to allow the fasteners to more easily be aligned with and engage the first support 140 and the second support 150.
Threaded holes (bores) in the first support 140 and the second support 150 can be provided to receive the fasteners 170 for attaching the outer prosthetic shell 200 to the first support 140 and second support 150. By way of the first support 140 and the second support 150, the outer prosthetic shell 200 can be attached to the elongated member 110.
As best shown in the cross-sectional view of
As can be seen in the cross-sectional view of
The profile of the first support 140 and the second support 150 can also be customized as shown in
As mentioned herein, the first and second supports 140, 150 are fixedly attached to the elongated member 110 such that the supports 140, 150 do not rotate and do not move axially along the elongated member 110. However, the first and second supports 140, 150 are fixedly attached to the outer prosthetic shell 200 and the elongated member 110.
Thus, the first and second supports 140, 150 are multi-purpose objects that are multi-functional and not only support and provide attachment points and also allow for the passage and routing of other internal objects as described herein.
Optional Features
The system 100 can also include optional functionality in the form of optional components that can be used with the system 100. These components can include electronics and a power source for powering the electronics. As described herein, the incorporation of electronics necessitates the use of a user interface to allow user control over the electronics. For example, as illustrated in
An actuator 320 is provided to allow the user to control operation of the main controller 300. The actuator 320 can be in the form of a switch or button that is provided along the outer surface of the outer prosthetic shell 200. The actuator 320 can be connected to the main controller 300 by a wire.
A recharging port 330 can be provided along the outer prosthetic shell 200 and is electrically connected to the power source 310. The recharging port 330 can be connected to the power source 310 using a wire or the like. As illustrated, the recharging port 330 is located closer to the power source 310 compared to the main controller 300. The recharging port 330 can be located on one side of the outer prosthetic shell 200 while the actuator 320 can be located on another side of the outer prosthetic shell 200. The recharging port 330 can be any number of types of ports that permit a direct charging of the battery 310. For example, it can be a traditional male plug or it can be any of the commercially available USB type connections or any other suitable connection.
Additional automated components can be included such as a powered wrist 400 that is electrically connected to the main controller 300 and can comprise any number of suitable commercially available products. The powered wrist 400 is thus for placement at the distal end of the outer prosthetic shell 200 and a prosthetic hand 500 can also be provided and coupled to the wrist 400.
As best shown in
The main controller 300 can also be thought of as being an electronic control module (ECM). The ECM is intended to be electrically connected, via a wire, to the wrist and hand to permit power and control over these components.
As discussed herein, the first support 140 and the second support 150 are each configured in view of the electronics that are contained within the outer prosthetic shell 200. In particular, the first support 140 and the second support 150 allow for the routing of wires and the like in an axial direction internally within the outer prosthetic shell 200. This functionality can be accomplished using the secondary openings 180 and the notch 195 also accommodates the functionality of the device by accommodating the actuator and its operation.
To load the battery 310, the battery 310 is slid through the through hole 159 and is delivered into the recessed portion 149.
It will be appreciated that the locations of the recessed portion 149 and through hole 159 can be reversed in that the recessed portion 149 can be formed in the second support 150 and the through hole 159 can be formed in the first support 140.
While
In addition, the shell 700 can optionally include one or more stops 750 that are formed along the inner surface of the shell 700 and serve to restrict and prevent distal movement of the insert 710 within the shell 700.
In
In this embodiment, the insert 710 is a single part that can be easily inserted into the hollow interior of the shell 700 and then moved to the correct target position therein where is it secured in placed as by using fasteners or other techniques.
The foregoing description of the specific embodiments will so fully reveal the general nature of the invention that others can, by applying knowledge within the skill of the art (including the contents of the references cited herein), readily modify and/or adapt for various applications such specific embodiments, without undue experimentation, without departing from the general concept of the present disclosure. Therefore, such adaptations and modifications are intended to be within the meaning and range of equivalents of the disclosed embodiments, based on the teaching and guidance presented herein. It is to be understood that the phraseology or terminology herein is for the purpose of description and not of limitation, such that the terminology or phraseology of the present specification is to be interpreted by the skilled artisan in light of the teachings and guidance presented herein, in combination with the knowledge of one of ordinary skill in the art.
The present disclosure is directed to an upper extremity prosthesis and more particularly, U.S. Ser. No. 63/007,053, filed Apr. 8, 2020, which is hereby expressly incorporated by reference in its entirety.
Filing Document | Filing Date | Country | Kind |
---|---|---|---|
PCT/US2021/026200 | 4/7/2021 | WO |
Number | Date | Country | |
---|---|---|---|
63007053 | Apr 2020 | US |