MEDICAL DEVICE FOR BLOOD VESSEL COMPRESSION
20220142654 · 2022-05-12
Inventors
Cpc classification
A61B2017/12004
HUMAN NECESSITIES
A61B2090/0811
HUMAN NECESSITIES
International classification
Abstract
Present invention relates to a medical device for blood vessels compression that is applied to a limb of a patient in order to achieve local haemostasis. The compression device of the invention is equipped with a compression control mechanism distal to the compression area, which controls the compression of the device onto the patient's limb by adjusting the tension of the strap used for attaching the device to the patient's limb. The device further comprises a stabilising support, which prevents the device from changing its position, when it is applied to the patient's limb.
Claims
1. A blood vessel compression device for a limb comprising: a hollow body having an internal substantially annular surface and a longitudinal base defining and accessible by a generally tubular space; a compression area located at an external surface of the base; a compression control mechanism for regulating compression applied by the device, wherein the mechanism is located on the body distal to and opposite the compression area and the base; a strap for securing the device to the limb and effecting compression thereon, the strap being attached to body at the base and releasably attachable with and adjustable by the compression control mechanism without blocking the tubular space; a support for stabilising the device, the support being located adjacent the base and extending in a longitudinal direction parallel therewith.
2. The device of claim 1, wherein the longitudinal base is a flattened surface that partly forms the internal substantially annular surface of the body.
3. The device of claim 1, wherein the compression control mechanism is a screw and nut mechanism.
4. The device of claim 3, wherein the screw-and-nut mechanism comprises: an externally-threaded element in a form of a screw with the rotation axis perpendicular to the compression area, which is provided with a plurality of thread-cutting guiding slots that are parallel to the rotation axis of said externally-threaded element, a knob in a nut-like form, which is fitted over the externally-threaded element in an engaging manner, and a tightener, which is positioned on the knob, wherein the tightener comprises a housing and the knob supporting and guiding elements, which protrude from the housing in the direction of and perpendicularly to the compression area, wherein said knob supporting and guiding elements are received by the guiding slots of the externally-threaded element.
5. The device of claim 4, wherein the externally-threaded element is provided with four guiding slots positioned symmetrically on the externally-threaded element, and the tightener is provided with two corresponding pairs of the knob supporting and guiding elements, and wherein each pair of the knob supporting and guiding elements is received by a pair of guiding slots positioned opposite to each other.
6. The device of anyone of claim 1, wherein the support is in a form of a bent fin of a wave-type cross section, which at the free end thereof is provided with a foot, wherein only the foot the support is in the same plane as the compression area.
7. The device of claim 1, wherein the compression control mechanism is configured to emit an audible click upon adjustment.
8. The device of anyone of claim 1, wherein the clicking sound producing means comprise: a ring spring, which is fixed within the housing of the tightener and has at least one protrusion that extends towards the knob, and cogs uniformly spaced along the rim of the knob in the proximity of the tightener, so that upon rotation of the knob the protrusion engages with one of the cogs thereby producing a clicking sound.
9. The device of anyone of claim 1, wherein the strap is attached to the hollow body at the compression area by an adhesive, wherein the attachment is formed over the entire compression area.
10. The device of claim 1, wherein the compression area and the foot of the support are provided with elastic insets.
11. The device of claim 1, wherein all of the device components are made of transparent plastic material.
12. A method of achieving local haemostasis of a blood vessel at a patient's limb, while maintaining blood flow through other blood vessels in the proximity of the bleeding blood vessel, comprising the steps of applying the medical device of one claim 1 at a bleeding vessel site by pressing manually the compression area the body against the bleeding vessel site, securing the device on the patient's limb by applying the strap around the patient's limb and over the compression control mechanism thus effecting compression of the device onto the patient's limb, and adjusting the compression of the device on the patient's limb by altering the tension of the strap by compression control mechanism.
13. The method of claim 12, wherein the tension of the strap is altered when the knob of the compression control mechanism is turned and moves away or towards the compression area.
14. The method of claim 13, wherein the compression of the device onto the patient's limb is increased as the knob moves away from the compression area and the tension of the strap increases.
15. The method of claim 13, wherein the compression of the device onto the patient's limb is decreased as the knob moves towards from the compression area and the tension of the strap decreases.
16. The method of claim 12, wherein the blood vessel is a radial artery from which a catheter or a cannula is being removed.
17. The method of claim 12, wherein the blood vessel is an ulnar artery from which a catheter or a cannula is being removed.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] The present invention will be described in a greater detail herein below in reference to a drawing wherein:
[0024]
[0025]
[0026]
[0027]
[0028]
[0029]
[0030]
[0031]
[0032]
DETAILED DESCRIPTION
[0033] The present invention relates to a vessel compression device 1.
[0034] Whenever a reference is herein made to a term “bottom” or “below” or “underneath” with respect to the device 1 or an element thereof, it means a part of the device 1 proximal to the patient and limb desired to be compressed, when the device 1 is properly attached to said limb. The term “downwards” also means in a direction towards the patient's limb.
[0035] The term “top” or “above” as used herein in reference to the device 1 or an element thereof, refers to the part of the device 1, which is located distal from the patient's limb, when the device 1 is properly attached to said limb. The term “upwards” refers to a distal direction from the patient's limb.
[0036] The device 1 of the invention has been designed to apply proper compression forces in the specific area of the limb in order to prevent bleeding from an injured blood vessel. At the same time, the device 1 does not apply forces to other major blood vessels in a patient's limb.
[0037] As presented in
[0038] On the opposite side to the strap 4 attachment site, i.e. at the top, the device 1 is provided with a tightener 30 and a knob 31, both of which are in a bolt-nut movable connection with hollow body 2, in particular with the externally-threaded element 21 of the hollow body 2. The tightener 30 is supported by the knob 31, which is located underneath of the tightener 30. After the device 1 is assembled, the tightener 30 and the knob 31 move together relative to the hollow body 2 along the externally-threaded element 21 of the hollow body 2. The movement of the tightener 30 relative the hollow body 2 provides control of the compression of the device 1 onto the patient's limb.
[0039] As shown in
[0040] The hollow body 2, in embodiments, is provided with a support 20, which may be an integral part of the hollow body 2. The support 20 extends from a side of the hollow body 2 (i.e. from the side wall 22 of the hollow body 2 near the base 26 of the hollow body 2), and away from the compression area 24.
[0041] In the preferred embodiment, the support 20 is in a form of a bent fin having a wave-type cross section. Initially, as it extends away from the hollow body 2, the bent fin of the support 20 is directed upwards to the inflection point where its direction changes towards the plane of the compression area 24. The support 20 does not extend beyond the plane of the base 26 of the hollow body 2. Moreover, at its free end (i.e. opposite to the site where the support 20 is connected to the side wall 22 of the hollow body 2), the support 20 is equipped with a supporting foot 200. When the device is applied to the patient's limb, the support 20 is in contact with a patient's limb, at a certain distance from the compression area 24. The contact of the support 20 is provided only by its free end or by the foot 200 of the support 20 as presented in this embodiment. That way, the device 1 does not compress other major blood vessels, which are in the vicinity of the blood vessel undergoing the medical procedure. Thus, the distance between the compression area 24 and the supporting foot 200 of the support 20 provides the space without compression that results in an undisturbed blood flow in other blood vessels that are not intended to be compressed in the medical procedure. Therefore, the contact of the device 1 with the surface of the palm side of the patient's forearm is limited to the minimum, i.e. to the compression area 24 and the free end of the support 20 or the foot 200 if it is present at the free end of the support 20, thus decreasing the discomfort level in a patient when device 1 is applied.
[0042] Despite its limited contact to the patient's limb, the support 20 provides an additional support to the device 1. The function of support 20 is, therefore, to stabilize the hollow body 2 on a patient's limb and consequently prevent any undesired movement of the device 1 after it is secured to the patient's limb. Without the support 20, the device would be prone to tipping sideways due to the forces that are applied by the strap 4. Preferably, the support 20 has a wave-type shape, as shown in
[0043] In the presently described embodiment, the hollow body 2, which is in a form of the tube, includes the side walls 22, which extend from base 26 circumferentially and are connected at the top by the externally-threaded element 21. Inside of the tube, between the base 26, side walls 22 and externally-threaded element 21 (i.e. within a periphery formed by the side walls 22, base 26 and externally-threaded element 21), there is a tubular space 23. The tubular space 23 is designed to receive a finger or a thumb of a medical personnel who, upon application of the device onto the patient's limb, puts initial compression onto the compression area 24 by pressing the base 26 of the hollow body 2. In order to provide a better access to the base 26 of the hollow body 2, the width of the side walls 22 decreases as they extend upwards (i.e. the walls gradually become narrower). The hollow body 2 is designed in a manner that the tubular space 23 can be accessed from both sides of the hollow body 2 (i.e. the tube forming the hollow body 2 is opened on both endings). This way the device is suitable to be used on both left and right forearms of the patient. This ensures a universal character of the device.
[0044] The side walls 22 provide support for a top part of a hollow body 2—the externally-threaded element 21, which forms an integral part of the hollow body 2. In the present embodiment, the externally-threaded element 21 has a shape of a hollow screw with the axis of rotation positioned perpendicularly to an axis of the tube of the hollow body 2. The axis of rotation of the externally-threaded element 21 is also perpendicular to the surface of the base 26 of the hollow body 2. This threaded element 21 has a plurality of grooves referred to as guiding slots 27, which extend in parallel to the rotation axis of the externally-threaded element 21. In this embodiment, there are four guiding slots 27 located symmetrically on the externally-threaded element 21. The guiding slots 27 are situated along the axis of rotation and perpendicularly to the thread of the externally-threaded element 21. When the device 1 is assembled, the guiding slots 27 receive the knob supporting elements 301 and guiding elements 302 of the tightener 30. This way the hollow body 2 and the tightener 30 are engaged with each other. Two of the guiding slots 27, which are located opposite to each other and receive the guiding elements 302 of the tightener 30, are provided at the top with blocking protrusions 270. As the tightener 30 moves upwards, these blocking protrusions 270 engage with free ends of the guiding elements 302 of the tightener 30, thus blocking their further upward movement and preventing the tightener 30 from becoming disengaged from the hollow body 2. The other pair of guiding slots 27, which are also located opposite each other, receives knob supporting elements 301 of the tightener 30.
[0045] The hollow body 2 in the assembled form of the device 1 engages with the tightener 30, which is placed above the hollow body 2.
[0046] The anti-skid inset 33 engages with the strap 4, which extends around the patient's limb and is guided over the hollow body 2 and tightener 30, between the longitudinal ribs 305 of the strap guide 304. The strap 4 extends in the direction perpendicular to the axis of the tube of the hollow body 2 and is led above and across of the hollow body 2, in a way that does not obstruct access to the tubular space 23 inside the hollow body 2. According to the preferred embodiment, as shown in
[0047] The guiding elements 302, not only guide the tightener 30 in reciprocating movement without rotation, but also limit the tightener 30 movement in the predefined range, by stopping the movement, when the bottom parts of the guiding elements 302 reach the top rim of the of the externally-threaded element 21 of the hollow body 2. The knob supporting elements 301 not only guide the tightener 30 in reciprocating movement without rotation, but also move the tightener 30 together with the knob 31 that is turned along the thread of the externally-threaded element 21, especially in the downward direction. During the upward movement, the knob 31 raises the tightener 30, as the tightener 30 is paced on the top of the knob 31.
[0048] All the elements of the tightener 30—the housing 300, supporting 301 and guiding 302 elements, and a strap guide 304—are formed as an integral element from plastic material. Preferably, the plastic material is transparent, which renders this element very aesthetic, but also is useful in the medical application of this component, as it does not obstruct the view of the patient's limb, in particular the vessel puncture site. In the most preferred embodiment the tightener 30 is made of polycarbonate by injection moulding. Thanks to its construction, the tightener 30 is easily released from the injection mould.
[0049] The movement of the tightener 30, and thus the compression control of the device 1, is possible due to a system comprising both the tightener 30 and the knob 31. The knob 31 as presented in
[0050] The knob 31 performs both rotating and reciprocating movement, wherein the reciprocating movement of the knob 31 causes the reciprocating movement of the tightener 30. This reciprocating movement is a movement of the compression control mechanism 3, which adjusts the compression force of the device 1 onto the patient's limb. The rotating movement of the knob 31 by engagement of the external thread of the externally-threaded element 21 of the hollow body 2, onto which the knob 31 is screwed with its internal thread 312, enforces reciprocating movement of the compression control mechanism 3 perpendicularly to the limb. Such movement of the compression control mechanism 3 adjusts the strap 4 compression on the device 1, thus regulating the compression of the device 1 onto patient's limb. Further, the knob 31 in its top area has a peripherally situated groove. This grove is provided with cogs 310, which preferably are formed in a way of gearwheel teeth, i.e. the cogs 310 are protrusions, which are separated by recesses. The cogs 310 interact with the ring spring 32 placed within the housing 300 of the tightener 30 and upon rotation of the knob 31 produce the clicking sound. This clicking sound is an audio confirmation that the rotation of the knob 31 takes place, which further corresponds to the information regarding the compression of the device 1.
[0051] Similarly to the other elements of the device 1 all edges of the knob 31 are rounded not only for aesthetic purposes, but also to prevent any injury to the patient. Moreover, according to preferred embodiment, the knob 31 is formed from plastic material. More preferably, it is formed by injection moulding from a transparent plastic material, such as poly(ethylene terephthalate). The transparency of this element is advantageous for the same reasons as already described for other components of the device 1.
[0052] The radial compression device 1 is provided with a compression regulation element consisting of the tightener 30 and the knob 31. In accordance with the preferred embodiment of the invention the device 1 is provided with means for indicating of the displacement of the tightener 30 and the knob 31 to facilitate the compression control. Apart from the pointers 311 and value indicators located on the knob 31, in the preferred embodiment of the invention, the device is provided with audio means for indicating the rotation of the knob 31. For that purpose a ring spring 32 is provided. The ring spring 32, as shown in
[0053] In the assembled device 1, the ring spring 32 is placed within the dome of the housing 300, so that it is adjacent to the surrounding walls of the housing 300, the blocking tongues 321 are inserted between the adjacent studs 303 of the housing 300, and the protrusions 320 extent downward towards the recesses between the cogs 310 of the knob 31. In the preferred embodiment the ring spring 32 is bent, so that its parts equipped with protrusions 320 project from the plane of the spring ring 32 in the direction of the knob 31. Moreover, the ring spring 32 is formed from plastic material. In the preferred embodiment the plastic material is elastic to ensure the desired flexibility of the ring spring 32. In the most preferred embodiment the ring spring 32 is made of polyetherimide, which provides both flexibility and durability of the ring spring 32. The use of the ring spring 32 is very advantageous because it provides the clicking mechanism and, at the same time, does not increase the dimensions of the device 1 (i.e. the clicking mechanism has been significantly miniaturized).
[0054] As described above, the movement of aforesaid compression control mechanism 3, which comprises the tightener 30 and the knob 31, is responsible for tightening or loosen the strap 4 extending around the patient's limb and the tightener 30. This way, the device 1 provides easy control of the compression force applied to blood vessels in the limb. While the knob 31 is rotated, it provides reciprocating movement of the compression control mechanism 3 in a direction perpendicular to the surface of the limb. Upon upward movement of the tightener 30, the increasing tension is applied to a strap 4, which in turns generates the increased compression of the hollow body 2 onto the patient's limb.
[0055] The strap 4 is an integral element, i.e. it is formed from a single piece of a plastic material. In the preferred embodiment the strap 4 has also anti-slip properties, i.e. the surfaces thereof when in contact do not slide against each other. This also increases the stability of the device 1, when it is applied to the patient's limb. Preferably, the strap 4 is transparent, i.e. it does not obstruct the view of the patient's limb. At the same time, the strap 4 is elastic, it can be wrapped around the patient's limb and over the top of the device 1. As shown in
[0056] The narrow strap part 41 extents, preferably gradually, into the wide strap part 42. When the device is applied into the patent's limb the wide strap part 42 is in contact with the dorsal side of patient's limb. The increased width of the strap 4 in this section increases patient's comfort and stability of the device when it is applied to the limb. The wide strap part 42 is preferably provided with two guiding edges 44, which extend in the lengthwise direction of the strap 4 and form a groove. The distance between the guiding edges 44 corresponds to the width of the narrow strap part 41, which is received in the groove formed between the guiding edges 44, when the device 1 is applied to the limb. The guiding edges 44 ensure that the narrow strap part 41 is held in place when the strap 4 is wrapped around the patient's limb.
[0057] The strap 4 is connected to the hollow body 2 by the connection strap part 43. The connection between the strap 4 and the hollow body 2 is durable, since it withstands forces associated with tension generated by upward movement of the tightener 30. In the present embodiment, the connection strap part 43 is connected to the hollow body 2 by an adhesive 5 that is placed between the connection strap part 43 and the compression area 24 of the hollow body 2. In addition, on the surface opposite to the adhesive 5, the connection strap part 43 is provided with the compression inset 45 (i.e. the compression inset 45 faces the limb of the patient). The compression inset 45 is preferably formed from an elastic material and provides additional compression in desired area of the limb.
[0058] The vessel compression device 1 according to the preferred embodiment, as shown in
LIST OF ELEMENTS
[0059] 1—a vessel compression device [0060] 2—a hollow body/tube [0061] 20—a support [0062] 200—a supporting foot of the support [0063] 21—an externally-threaded element [0064] 22—a side wall of the hollow body [0065] 23—a tubular space [0066] 24—a compression area (i.e. the outer surface of the longitudinal base) [0067] 25—a positioning mark [0068] 26—a longitudinal base [0069] 27—a guiding slot [0070] 270—a blocking protrusion [0071] 3—a compression control mechanism [0072] 30—a tightener [0073] 300—a housing [0074] 301—a knob supporting element [0075] 302—a guiding element [0076] 303—a stud [0077] 304—a strap guide [0078] 305—longitudinal ribs of the strap guide [0079] 31—a knob [0080] 310—a cog [0081] 311—a pointer [0082] 312—a internal thread [0083] 32—a ring spring [0084] 320—a protrusion [0085] 321—a blocking tongue [0086] 33—an anti-skid inset [0087] 4—a strap [0088] 40—a locking sticker at the free end of the strap [0089] 41—a narrow strap part [0090] 42—a wide strap part [0091] 43—a connection strap part [0092] 44—guiding edges [0093] 45—a main compression inset [0094] 5—an adhesive for securing the strap to the hollow body