AN ADJUSTABLE COMPRESSION SLEEVE FOR AMPUTATED SUBJECTS AND METHODS OF USING THE SAME
20240041693 ยท 2024-02-08
Inventors
Cpc classification
International classification
Abstract
Provided herein is an inflatable compression device for performing compression therapy to an amputated limb of a subject, the device includes a compression sleeve and an adjustable compression pocket configured to provide compression therapy to the stump face and adjust to the length of the amputated limb. Further provided are systems and methods of using the same.
Claims
1.-38. (canceled)
39. An inflatable compression device for providing compression therapy to an amputated limb of a subject, the compression device comprising a compression sleeve configured to be surroundingly engageable with the amputated limb and an adjustable compression pocket configured to engage a stump face of the amputated limb, to thereby provide compression therapy to the stump and at least a portion of the limb.
40. The inflatable compression device according to claim 39, wherein the adjustable compression pocket is retractable.
41. The inflatable compression device according to claim 39, wherein the adjustable compression pocket is in the form of bellows, configured to inflate or deflate.
42. The inflatable compression device according to claim 39, wherein the height or length of the adjustable compression pocket is configured to be adjusted.
43. The inflatable compression device according to claim 39, wherein the adjustable compression pocket comprises an external cover, said external cover comprising one or more fastening means configured to allow controlling the degree of height or length adjustment of the compression pocket.
44. The inflatable compression device according to claim 39, wherein the compression sleeve comprises one or more bladders configured to be inflated and deflated to thereby provide compression therapy to at least a portion of the limb.
45. The inflatable compression device according to claim 39, wherein the adjustable compression pocket is functionally and/or physically associated with the compression sleeve.
46. The inflatable compression device according to claim 39, wherein the adjustable compression pocket is located substantially horizontally relative to the compression sleeve, such that the adjustable pocket is engaged or is in contact with the stump face and the sleeve is engaged or is in contact with a circumferential portion of the limb.
47. The inflatable compression device according to claim 39, further comprising a harness configured to engage a body part of the subject to attach or secure the compression sleeve and/or the compression pocket to the amputated limb.
48. The inflatable compression device according to claim 39, wherein the harness is adjustable to conform to the body part of the subject.
49. A system for providing compression therapy to an amputated limb of a subject, the system comprising: the inflatable compression device according to claim 39; and a controller unit configured to control the operation of inflatable compression device.
50. The system according to claim 49, further comprising a fluid compressor configured to inflate or deflate the compression sleeve and/or the adjustable compression pocket.
51. The system according to claim 49, further comprising one or more valves, configured to control pressure in bladders of the compression sleeve and/or the in adjustable compression pocket; a user interface and/or a communication unit
52. The system according to claim 49, configured to inflate, deflate or maintain pressure in the compression sleeve and/or the adjustable compression pocket, in accordance with a compression therapy session.
53. The system according to claim 49, configured to adjust the compression device to the length of the amputated limb.
54. The system according to claim 49, wherein the one or more bladders of the compression sleeve and/or the adjustable compression pocket are configured to inflate and/or delate in synchronization, concomitantly or sequentially.
55. A method for providing a compression therapy to an amputated limb of a subject in need thereof, the method comprising: placing an adjustable compression device according to claim 39, on the subject, such that the compression sleeve is engageable with at least a portion of the limb; adjusting the height or length of the adjustable compression pocket to conform to the length of the amputated limb, such that the compression pocket is at least partially in contact with the face of the stump; and controlling the pressure in the inflatable compression device to provide a compression therapy to the amputated limb.
56. The method according to claim 55, wherein controlling the pressure in the inflatable compression device comprises reducing, maintaining, or increasing the pressure in one or more bladders of the compression sleeve and/or the in the adjustable compression pocket.
57. The method according to claim 55, wherein adjusting the height or length of the adjustable compression pocket is facilitated by introduction of fluid into the pocket.
58. The method according to claim 55, wherein the compression therapy is configured to result in one or more of: enhancing blood circulation, reducing lymphatic fluid accumulation in the amputated limb, reducing and controlling post-surgical edema, reducing pain, enhancing wound healing, controlling chronic lymphedema, or any combination thereof.
Description
BRIEF DESCRIPTION OF THE FIGURES
[0048] Some embodiments of the invention are described herein with reference to the accompanying figures. The description, together with the figures, makes apparent to a person having ordinary skill in the art how some embodiments may be practiced. The figures are for the purpose of illustrative description and no attempt is made to show structural details of an embodiment in more detail than is necessary for a fundamental understanding of the invention. For the sake of clarity, some objects depicted in the figures are not to scale.
[0049] In the Figures:
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DETAILED DESCRIPTION
[0057] The principles, uses and implementations of the teachings herein may be better understood with reference to the accompanying description and figures. Upon perusal of the description and figures present herein, one skilled in the art will be able to implement the teachings herein without undue effort or experimentation. In the figures, same reference numerals refer to same parts throughout.
[0058] In the description and claims of the application, each of the words comprise include and have, and forms thereof, are not necessarily limited to members in a list with which the words may be associated.
[0059] As used herein, right and left refer to the right and left directions from the center of body of a subject. In some embodiments, left and right are determined by the sagittal plane (longitudinal, anteroposterior), which is parallel to the sagittal suture. In some embodiments, the terms left and left hand side may interchangeably be used. In some embodiments, the terms right and right hand side may interchangeably be used.
[0060] As used herein, the terms top and bottom refer to top and bottom directions of a subject body. In some embodiments, top is relatively closer to the head region and lower is relatively closer to the leg region. In some embodiments, top and bottom are relative to the transverse plane (axial or horizontal plane), which divides the body into cranial and caudal (head and tail) portions. In some embodiments, a compression device is placed on the body of the subject, such that the sleeve is at least partially soundingly engageable with the circumference of the limb and the adjustable compression pocket is configured to engage the face of the stump.
[0061] As used herein, the terms bladder, inflatable bladder, compartment, and chamber cell, may interchangeably be used. The terms relate to a cell capable of being inflated, deflated, or maintain fluid therein. In some embodiments, the bladders disclosed herein may be linearly arranged in a compression sleeve. The bladders may be separate from one another or may have some overlap therebetween. In some embodiments, the bladders are at least partially fluidly connected thereto.
[0062] As used herein, the terms pocket, adjustable compression pocket, adjustable pocket, adjustable cell, adjustable compression cell may interchangeably be used. The terms relate to a cell capable of being inflated, deflated, or maintain fluid therein. In some embodiments, the pocket has foldable walls. In some embodiments, the pocket is collapsible, retractable, foldable, or the like, such that the height/length thereof may be adjusted. In some embodiments, the pocket is in the form of a bellow (also referred to as Accordion or Garmoshka forms), which is a collapsible chamber (flexible bag) whose volume can be changed by, for example, compression or expansion.
[0063] As used herein, the term subject and patient may interchangeably be used. The term relates to a subject having an amputated limb. In some embodiment, the limb may be a leg. In some embodiments, the limb maybe an arm. The amputation location/position along the limb is the stump region. In some embodiments, the location/position of the amputation, affects the length of the amputated limb. For example, in an amputated leg, the amputation location may be below or above the knee. In some embodiments, the amputated limb length is determined as the distance (length) between the face of the sump and an opposing end of the limb (for example, hup, shoulder, etc.). In some embodiments, the amputation may be related to a disease (such as, cancer, diabetes), an accident or an injury.
[0064] As used herein, the term treating relates to application of compression therapy to an amputated subject in need thereof. In some embodiments, the compression therapy is a pneumatic compression therapy. In some embodiments, the compression therapy includes a session of therapy, in the length of about 1-60 minutes, whereby continuous or intermittent pressure is applied amputated limb (circumference and/or stump thereof). In some embodiments, the treatment can at least partially ameliorate one or more symptoms associated with or related to the amputation, including, for example, but not limited to: enhancing blood circulation, reducing lymphatic fluid accumulation in the amputated limb, reducing and controlling post-surgical edema, reduce pain, enhance wound healing, control chronic lymphedema, or any combination thereof. In some embodiments, the treatment may be performed, for example, while the subject is standing, sitting or walking.
[0065] As used herein, the term health care provider, user, physician relate to a provider of therapy to a subject in need thereof.
[0066] As used herein, the term about is used to specify a value of a quantity or parameter (e.g. the length of an element) to within a continuous range of values in the neighborhood of (and including) a given (stated) value. According to some embodiments, about specifies the value of a parameter to be between 80% and 120% of the given value. For example, the statement the length of the element is equal to about 1 m is equivalent to the statement the length of the element is between 0.8 m and 1.2 m. According to some embodiments, about specifies the value of a parameter to be between 90% and 110% of the given value. According to some embodiments, about specifies the value of a parameter to be between 95% and 105% of the given value.
[0067] According to some embodiments, there is provided an advantageous adjustable compression device, having a compression sleeve which includes one or more inflatable bladders configured to provide compression therapy to circumference of an amputated limb, with which they are engaged, and an advantageous adjustable compression pocket, in the form of a below, configured to adjust in height/length to the length/size of the amputated limb, such that it is engaged with the stump face, to provide compression therapy thereto.
[0068] Reference is now made to
[0069] Reference is now made to
[0070] Reference is now made to
[0071] As shown in
[0072] Reference is now made to
[0073] Reference is now made to
[0074] Reference is now made to
[0075] According to some embodiments, the bladders and/or may be constructed of any suitable material. For example, walls of the bladders may be made of such materials as, but not limited to: polyethylene (PE), ethylene-vinyl acetate (EVA), or polyvinyl chloride (PVC), thermoplastic polyurethane (TPU), and the like or combinations thereof
[0076] According to some embodiments, the ventilation openings of the bladders and/or pocket are configured to allow for the pumping/insertion of fluid (such as, air) into the bladder, and the outflow of fluid (for example by passive or active deflation) from, the bladders, thereby inflating and deflating the bladders and/or pocket. According to some embodiments, the ventilation openings may be in the form of a female connector (for example, in the form of a socketed member), or in the form of a male connector (for example, in the form of tubular spouts). Apart from the fluid connectivity provided by the ventilation openings (fluidly connecting the inside of each of the bladders to the outside), the bladders and/or pocket are fluidly sealed (i.e., airtight). In some embodiments, the ventilation openings may each be connected to a separate fluid tube/hose. In some embodiments, at least some of the ventilation openings may be connected to a common fluid tube/hose.
[0077] According to some embodiments, the pressure in each of the bladders and/or pocket may independently be in the range of about 1-150 mmHg. According to some embodiments, the pressure in each of the bladders and/or pocket may independently be in the range of about 10-130 mmHg. According to some embodiments, the pressure in each of the bladders and/or pocket may independently be in the range of about 15-120 mmHg. In some embodiments, each of the bladders and/or pocket may be configured to inflate, deflate or maintain similar or different pressures.
[0078] According to some embodiments, the compression device, or portions thereof may be disposable. According to some embodiments, the compression device may washable and reusable.
[0079] According to some embodiments, the operation/control of operation of the compression device may be utilized using one or more suitable controllers, allowing the inflation/deflation of the inflatable bladders, in order to provide compression therapy to the subject.
[0080] According to some embodiments, the systems and devices disclosed herein may be used in method of applying compression therapy to an amputated limb of a subject in need thereof.
[0081] According to some embodiments, the compression therapy system may be utilized continuously or intermittently over any desired period of time beneficial for the subject. In some embodiments, the treatment may be provided is sessions. In some embodiments, the treatment session may be repeated at least once, 2, 4, 6 or more times a day, at any desired time interval therebetween. In some embodiments, each two consecutive treatment sessions may be identical, similar or different therefrom. In some embodiments, the length of a treatment session may be in the range of about 2 minutes to about 6 hours. In some embodiments, the length of a treatment session may be in the range of about 5 minutes to about 1 hour.
[0082] According to some embodiments, there is provided a method for providing or applying a compression therapy to an amputated limb of a subject utilizing the advantageous compression device as disclosed herein. According to some embodiments, the compression treatment may include inflating/deflating and/or maintaining pressure in one or more of the bladders and/or the pocket.
[0083] According to some embodiments, controlling the pressure in the compression device may include reducing, maintaining, or increasing the pressure in one or more bladders and/or pocket. In some embodiments, the pressure in each bladder may be similar. In some embodiments, the pressure may change individually in each bladder. In some embodiments, the pressure may change concomitantly in all bladders, or at least in some of the bladders.
[0084] According to some embodiments, the compression cycles/sessions may be sequential, peristaltic or intermittent, and may be adjusted based on the treatment. The compression cycle may be adjusted according to the order of inflation/deflation of the various bladders/pocket, length of the deflation/inflation, and the like. For example, peristaltic compression may be facilitated by keeping any number of chambers inflated in a given time (for example, one chamber, two chambers or more). In some embodiments, some chambers/bladders may be blocked, kept not inflated during the inflation cycle (i.e., skip chambers) according to the specific medical condition being treated.
[0085] According to some embodiments, various compression cycles/sessions may be utilized, in accordance with various parameters, including, for example, but not limited to: the type of limb (for example, arm, leg), characteristics of the subject (age, weight, gender, medical condition, medical history, and the like), the amputation status, amputation location, length of the stump, medical condition to be treated, and the like.
[0086] According to some embodiments, the controller unit includes a processing unit or module. According to some embodiments, terms such as processing, computing, calculating, determining, estimating, assessing, gauging or the like, may refer to the action and/or processes of a computer or computing system, or similar electronic computing device, that manipulate and/or transform data, represented as physical (e.g. electronic) quantities within the computing system's registers and/or memories, into other data similarly represented as physical quantities within the computing system's memories, registers or other such information storage, transmission or display devices. Embodiments of the present disclosure may include apparatuses for performing the operations herein. The apparatuses may be specially constructed for the desired purposes or may include a general-purpose computer(s) selectively activated or reconfigured by a computer program stored in the computer. Such a computer program may be stored in a computer readable storage medium, such as, but not limited to, any type of disk including floppy disks, optical disks, CD-ROMs, magnetic-optical disks, read-only memories (ROMs), random access memories (RAMs), electrically programmable read-only memories (EPROMs), electrically erasable and programmable read only memories (EEPROMs), magnetic or optical cards, or any other type of media suitable for storing electronic instructions, and capable of being coupled to a computer system bus. The processes and displays presented are not inherently related to any particular computer or other apparatus. Various general-purpose systems may be used with programs in accordance with the teachings herein, or it may prove convenient to construct a more specialized apparatus to perform the desired method(s). In addition, embodiments of the present disclosure are not described with reference to any particular programming language. It will be appreciated that a variety of programming languages may be used to implement the teachings of the present disclosure as described herein.
[0087] Aspects of the disclosure may be described in the general context of computer-executable instructions, such as program modules, being executed by a computer. Or processing unit. Generally, program modules include routines, programs, objects, components, data structures, and so forth, which perform particular tasks or implement particular abstract data types. Disclosed embodiments may also be practiced in distributed computing environments where tasks are performed by remote processing devices that are linked through a communications network. In a distributed computing environment, program modules may be located in both local and remote computer storage media including memory storage devices.
[0088] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination or as suitable in any other described embodiment of the invention. No feature described in the context of an embodiment is to be considered an essential feature of that embodiment, unless explicitly specified as such.
[0089] Although steps of methods according to some embodiments may be described in a specific sequence, methods of the invention may comprise some or all of the described steps carried out in a different order. A method of the invention may comprise all of the steps described or only a few of the described steps. No particular step in a disclosed method is to be considered an essential step of that method, unless explicitly specified as such.
[0090] Although the invention is described in conjunction with specific embodiments thereof, it is evident that numerous alternatives, modifications and variations that are apparent to those skilled in the art may exist. Accordingly, the invention embraces all such alternatives, modifications and variations that fall within the scope of the appended claims. It is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and/or methods set forth herein. Other embodiments may be practiced, and an embodiment may be carried out in various ways.
[0091] The phraseology and terminology employed herein are for descriptive purpose and should not be regarded as limiting. Citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the invention. Section headings are used herein to ease understanding of the specification and should not be construed as necessarily limiting.
EXAMPLES
Example 1Application of Compression Therapy to an Amputated Limb
[0092] The device for compression therapy is utilized to provide compression therapy to an amputated limb of a subject in need thereof. Various compression cycles may be utilized, in accordance with various parameters, including, for example, but not limited to: the limb, characteristics of the subject (age, weight, gender, medical condition, etc.), the amputation status, amputation location, length of the stump, medical condition to be treated, and the like.
[0093] After the compression device is placed and secured to the amputated limb, the compression therapy session/cycle may be initiated.
[0094] Listed below are details of three exemplary compression therapy cycles, whereby the order of inflation/deflation of the compression cells (i.e., bladders or compression pocket (also referred to as cell no. 1)) is adjusted according to the treatment session/cycle.
[0095] The compression chambers are numbered from 1 at the bottom cell (i.e., adjustable compression pocket) to 2, 3, 4 . . . N (bladders of the compression sleeve) as progressing towards the center of the body.
Compression cycles may be sequential, peristaltic or intermittent as exemplified below:
I. Sequential Compression Cycle:
[0096] Inflate #1 [0097] Inflate #2 [0098] Inflate #3 [0099] Inflate #N [0100] [0101] Deflate all chambers
II. Peristaltic Compression Session:
[0102] Inflate #1 [0103] Inflate #2 [0104] Deflate #1 [0105] Inflate #3 [0106] Deflate #2 [0107] Inflate #4 [0108]
[0109] Peristaltic compression is facilitated by keeping/maintaining any number of chambers inflated in given time (1 chamber, 2 chambers or more).
[0110] III. Intermittent Inflation Cycle: [0111] Inflate all chambers simultaneously [0112] Deflate all chambers
[0113] Chambers may be blocked, kept not inflated during the inflation cycle (skip chambers) according to the specific medical condition being treated.