阅读说明：本技术 医疗锚定装置 (Medical anchoring device ) 是由 理查德·莫德利 蒂姆·琼斯 米歇尔·蒂尔尼 于 2019-12-19 设计创作，主要内容包括：一种用于将医疗物品固定至受试者的医疗锚定装置(1),该医疗锚定装置(1)包括上部医疗物品附接部(2)和下部插入部(3),该下部插入部(3)用于将该医疗锚定装置(1)固定至受试者,其中,插入部(3)包括螺旋锚定件(5),通过根据螺旋锚定件(5)的方向的要求以顺时针或逆时针的方式旋转医疗锚定装置(1),使得医疗锚定装置(1)可固定至受试者并且可以从受试者拆卸。(A medical anchoring device (1) for securing a medical article to a subject, the medical anchoring device (1) comprising an upper medical article attachment portion (2) and a lower insertion portion (3), the lower insertion portion (3) being for securing the medical anchoring device (1) to a subject, wherein the insertion portion (3) comprises a helical anchor (5) such that the medical anchoring device (1) is securable to and detachable from a subject by rotating the medical anchoring device (1) in a clockwise or counter-clockwise manner as required by the orientation of the helical anchor (5).)

1. A medical anchoring device (1) for securing a medical article to a subject, comprising:

upper medical article attaching part (2) and

a lower insertion portion for subcutaneous fixation of the medical anchoring device to a subject, wherein the insertion portion comprises helical anchors (5) arranged substantially in a single plane.

2. The medical anchoring device (1) according to claim 1, wherein the helical anchor defines an archimedean helical shape.

3. The medical anchoring device (1) according to claim 1 or 2, wherein the helical anchor (5) extends laterally outwards from the medical article attachment portion (2).

4. The medical anchoring device (1) according to any one of claims 1 to 3, wherein the helical anchor (5) is flexible.

5. The medical anchoring device (1) according to any one of claims 1 to 4, wherein the helical anchor comprises a free insertion end (18) for insertion into a subject.

6. The medical anchoring device (1) according to any one of claims 1 to 5, further comprising a skin-receiving gap (24), the skin-receiving gap (24) being between the medical article attachment portion (2) and the screw anchor (5).

7. The medical anchoring device (1) according to claim 6, wherein the gap (24) comprises a slot-like gap (24).

8. The medical anchoring device (1) according to claim 6 or 7, wherein the gap (24) is defined by a spacer arm (25), the spacer arm (25) being between the medical article attachment portion (2) and the helical anchor (5).

9. The medical anchoring device (1) according to claim 8, wherein the spacer arm (25) is configured to define a curved skin abutment surface (26).

10. The medical anchoring device (1) according to claim 9, wherein the curved skin abutment surface (26) comprises a concave skin abutment surface (26).

11. The medical anchoring device (1) according to any one of claims 8 to 10, wherein the spacer arms comprise inflexible spacer arms (26).

12. The medical anchoring device (1) according to any one of claims 1 to 6, wherein the helical anchor (5) is attached to the medical article attachment portion (2) at a medical article attachment portion end (17) adjoining the medical article attachment portion.

13. The medical anchoring device (1) according to any one of claims 1 to 12, wherein the medical article attachment portion comprises a platform.

14. The medical anchoring device (1) according to claim 13, wherein the platform comprises a substantially cylindrical platform (4).

15. The medical anchoring device (1) according to claim 13 or 14, wherein the platform comprises a lumen (9).

16. The medical anchoring device (1) according to claim 15, wherein the lumen comprises a top opening (10) and a bottom opening (11).

17. The medical anchoring device (1) according to any one of claims 13 to 15, wherein the platform comprises a medical article mount (12, 15).

18. The medical anchoring device (1) according to claim 17, wherein the medical article mount (12) comprises a top medical article mount (13), the top medical article mount (13) being at the top opening (10).

19. The medical anchoring device (1) according to claim 17 or 18, wherein the medical article mount (12, 15) comprises a bottom medical article mount (15), the bottom medical article mount (15) being at the bottom opening (10).

20. The medical anchoring device (1) according to claim 18 or 19, wherein the top medical article mount (12) and/or the bottom medical article mount (15) comprises a thread (14).

21. The medical anchoring device (1) according to any one of claims 1 to 20, wherein the medical anchoring device (1) is a single medical anchoring device (1).

22. The medical anchoring device (1) according to any one of claims 1 to 21, wherein the medical anchoring device (1) is a multipart medical anchoring device (1).

23. The medical anchoring device (1) according to any one of claims 1 to 22, wherein the medical anchoring device (1) is a catheter anchoring device.

24. A medical anchoring system for securing a medical article to a subject, comprising a medical anchoring device (1) according to any one of claims 1 to 23 and a medical article engageable with the medical anchoring device (1).

25. The medical anchoring system for securing a medical article to a subject according to claim 24, wherein the medical article comprises an elongate element engageable with the medical anchoring device.

26. A medical anchoring system for securing a medical article to a subject according to claim 25, wherein the elongate element is a catheter or drainage tube.

27. The medical anchoring system for securing a medical article to a subject of claim 24, wherein the medical article comprises a pump.

28. The medical anchoring system for securing a medical article to a subject of claim 24, wherein the medical article includes a sensor.

29. The medical anchoring system for securing a medical article to a subject according to any one of claims 24 to 28, wherein the medical anchoring device (1) and the medical article comprise formations configured for mutual engagement to lock the medical article to the medical anchoring device (1).

30. A medical anchoring system for securing a medical article to a subject according to claim 29, wherein the formation comprises a thread.

31. A medical anchoring system for securing a medical article to a subject according to claim 29 or 30, wherein the configuration comprises a friction fit configuration.

32. A medical anchoring system for securing a medical article to a subject according to any of claims 29 to 31, wherein the formation comprises a re-entrant groove formation.

33. A method of attaching a medical article to a subject by subcutaneously securing the medical article with a medical anchoring device (1), comprising:

creating an incision at an insertion site in a subject;

inserting a medical anchoring device into the cut-out by inserting an insertion end of a helical anchor into the cut-out, the medical anchoring device having an upper medical article attachment portion (2) and a lower insertion portion (3), wherein the insertion portion (3) comprises the helical anchor (5) arranged substantially in a single plane, and

subcutaneously rotating the medical anchoring device in the incision to secure the medical anchoring device to the subject.

34. The method of claim 33, wherein a single incision is created at the insertion site.

35. The method of claim 34, wherein the single incision is a subcutaneous single incision.

36. The method according to any one of claims 33 to 35, wherein the medical anchoring device (1) is rotated through at least a half turn (180 °), at least a three-quarter turn (270 °), or at least a full turn (360 °).

37. Method according to any one of claims 33 to 36, wherein the medical anchoring device (1) is rotated in a clockwise or counterclockwise manner depending on the direction of the helical anchor.

38. The method according to any one of claims 33 to 37, wherein the medical anchoring device (1) is fully inserted after one complete rotation.

39. The method according to any one of claims 33 to 38, wherein the method further comprises the step of attaching a medical article to the medical attachment portion (2).

Technical Field

The present invention relates to a medical anchoring device for securing a medical article to a subject. More particularly, the present invention relates to a medical anchoring device for securing elongate medical articles (such as catheters, ports, pumps, tubes, and the like) to a subject. The invention also relates to a medical anchoring system comprising a medical anchoring device and a medical article, and to a method for securing a medical article to a subject.

Background

Proper securement of the medical article to the subject is critical to ensure optimal performance of the medical article. For example, a range of treatment areas require securing medical items (e.g., catheters or tubes) to a subject for fluid drainage, obesity treatment, waste excretion management, feeding, and intraperitoneal treatment management. In such treatments, it is necessary to mitigate the potential risk of catheter/tube problems (such as dislodgement, infection or occlusion, etc.). Thus, a variety of fixation methods are currently used in these treatment areas, ranging from balloon anchoring, sutures, adhesives, pigtail anchoring, and relatively invasive subcutaneous methods.

For example, U.S. patent specifications 4,164,943, 7,959,615, 2012/078191, 2006/079845, 5,496,283, 5,685,859, and 9,468,740 describe a series of medical device holders and systems, all of which require the use of adhesives, sutures, require relatively complex surgical procedures to secure the medical device holder to the subject, and/or are highly invasive and penetrate deeply into the subject. Adhesive fixation is known to fail over time and may cause severe allergic reactions, and the need to use sutures and complex surgical procedures requiring multiple incisions to secure the medical device holder can be time consuming and cause discomfort to the subject. In addition, many known medical device holders of the prior art are complex devices that may also be expensive to manufacture, difficult to use, and require surgical flexibility to properly configure.

In summary, a variety of different mechanisms are employed to secure medical articles (such as catheters, etc.), many of which are specific to a single treatment area and anatomic location, require invasive placement procedures, or are compatible with only certain catheter types.

It is an object of the present invention to overcome at least some of the problems of the prior art.

In the present description, reference is made to a medical anchoring device for a subject. As will be appreciated by those skilled in the art, the medical anchoring device of the present invention is suitable for use with human and animal subjects. Thus, the medical anchor may be used in human and veterinary medicine, and references to medicine and subjects should be construed to include both human and animal medicine and subjects.

Disclosure of Invention

According to the present invention, there is provided a medical anchoring device for securing a medical article to a subject, comprising:

an upper medical article attaching part, and

a lower insertion portion for subcutaneously securing the medical anchoring device to a subject, wherein the insertion portion comprises helical anchors arranged generally in a single plane.

In an embodiment, the helical anchor (5) defines an archimedean helical shape, i.e. the helical anchor is arranged in a single plane.

Preferably, the helical anchor extends laterally outward from the medical article attachment portion.

In an embodiment, the helical anchor comprises at least one full turn.

Preferably, the helical anchor is flexible.

Preferably, the helical anchor comprises a free insertion end for insertion into a subject.

In an embodiment, the medical anchoring device further comprises a skin-receiving gap between the medical article attachment portion and the helical anchor. Preferably, the gap comprises a slot-like gap. Suitably, the gap is defined by a spacer arm between the medical article connection and the helical anchor. More preferably, the spacer arm is configured to define a curved skin abutment surface.

In an embodiment, the curved skin-abutting surface comprises a concave skin-abutting surface.

Preferably, the spacer arms comprise inflexible spacer arms.

Suitably, the helical anchor is attached to the medical article attachment portion at an end of the medical article attachment portion adjacent to the medical article attachment portion.

In an embodiment, the medical article attachment portion comprises a platform. Preferably, the platform comprises a generally cylindrical platform. More preferably, the platform comprises a lumen. The cylindrical platform may have a cross-section that is generally circular, oval, square, rectangular, or any other shape.

In an embodiment, the medical article attachment portion comprises an adhesive for adhering the attachment portion to the subject around the incision.

Most preferably, the lumen comprises a top opening and a bottom opening.

Advantageously, the platform comprises a medical article mount. Preferably, the medical article mount comprises a top medical article mount at the top opening.

Optionally or additionally, the medical article mount comprises a bottom medical article mount at the bottom opening.

In an embodiment, the top medical article mount and/or the bottom medical article mount comprise threads. Other forms of mounting may be employed such as, for example, re-entrant grooves, friction fit mountings, adhesive mountings and clips or clamps.

In an embodiment, the medical anchoring device is a single medical anchoring device.

Alternatively, the medical anchoring device 1 is a multipart medical anchoring device.

The medical article is typically a medical device having a portion that is inserted into the body. Examples include elongated tubular articles such as catheters and drainage tubes. In a preferred embodiment of the invention, the medical anchoring device is a catheter anchoring device. Other items include pumps, ports and sensors, which are useful for anchoring to the skin.

The invention also extends to a medical anchoring system for securing a medical article to a subject (typically the skin of the subject), the medical anchoring system comprising a medical anchoring device as defined above and a medical article engageable with the medical anchor.

In a preferred embodiment, the medical article is comprised of an elongate element or includes an elongate element engageable with a medical anchor, such as a catheter or drainage tube. In other embodiments, the portion of the medical article that engages the anchor is not an elongate element, and may be, for example, a pump, a sensor, or the like. In embodiments, the anchor and medical article comprise formations, such as threads, friction fit formations or re-entrant groove formations, configured for mutual engagement to lock the article to the anchor.

In a further embodiment, the invention also extends to a method of securing a medical article to a subject (typically the skin of the subject) with a medical anchoring device as hereinbefore defined.

In an embodiment, the invention relates to a method of attaching a medical article to a subject by subcutaneously securing it with a medical anchoring device, comprising:

creating an incision at an insertion site in a subject;

inserting a medical anchoring device into the cut-out by inserting an insertion end of the helical anchor into the cut-out, the medical anchoring device having an upper medical article attachment portion and a lower insertion portion, wherein the insertion portion includes the helical anchor arranged substantially in a single plane, and

the medical anchoring device is subcutaneously rotated in the incision to secure the medical anchoring device to the subject.

Preferably, a single incision is created at the insertion site. More preferably, the single incision is a subcutaneous single incision.

In embodiments, the device is rotated through at least a half turn (180 °), at least a three-quarter turn (270 °), or at least a full turn (360 °).

Suitably, the medical anchoring device is rotated in a clockwise or counterclockwise manner depending on the direction of the helical anchor.

Preferably, the medical anchoring device is fully inserted after one complete rotation.

The method further comprises the step of attaching the medical article to the medical attachment.

The medical anchoring device of the present invention is generally applicable to the securement of medical articles across a range of treatment areas. The medical anchoring device is particularly suited for securing and securing in place catheters and other elongate or tubular articles that are widely used and particularly susceptible to displacement, such that the present invention also provides an efficient medical anchoring system comprised of the medical device anchor and a catheter engageable with the medical device anchor.

In general, the invention thus provides a medical anchoring device for securing a medical article to a subject, the medical anchoring device comprising an upper medical article attachment portion and a lower insertion portion for securing the medical anchoring device to the subject, wherein the insertion portion comprises a helical anchor.

The medical anchoring device is a simple, non-drilling, minimally invasive, conformable, subcutaneous medical article/catheter anchor that can be applied to a variety of anatomical locations and accommodate a variety of medical article/catheter types. In particular, the flexible helical anchor of the medical anchoring device facilitates fixed anchoring in tissue via a single subcutaneous incision point to ensure that the medical anchoring device is centrally positioned relative to the incision point such that the incision is centrally positioned within the lumen of the platform.

Thus, the subcutaneous medical anchoring device of the present invention enjoys many advantages over the prior art, namely, it:

a streamlined manner of ensuring the arrangement of the anchor;

less surgical time is required for placement compared to current invasive fixation methods;

no need for sewing;

no adhesive is required (although an adhesive may be used in addition);

has excellent fixing ability;

has a simple but effective overall structure;

cost-effective manufacture;

versatility-suitable for use in a range of medical articles and therapeutic applications, but particularly suitable for use with all types of catheters and the like;

is comfortable for the subject, and

easier removal compared to known invasive fixation methods.

All publications, patents, patent applications, and other references mentioned herein are incorporated by reference in their entirety for all purposes to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference and was set forth in its entirety herein.

Definition and general selection

As used herein and unless otherwise expressly indicated, the following terms are intended to have the following meanings in addition to any broader (or narrower) meanings these terms may have in the art:

unless the context requires otherwise, the use herein of the singular is to be understood to include the plural and vice versa. The use of the terms "a" or "an" in relation to an entity should be understood to refer to one or more of that entity. Thus, the terms "a" (or "an"), "one or more," and "at least one" are used interchangeably herein.

As used herein, the term "comprise" or variations thereof such as "comprises" or "comprising" will be understood to imply the inclusion of any stated integer (e.g., feature, element, characteristic, property, method/process step or limitation, etc.) or group of integers (e.g., features, elements, characteristics, property, method/process step or limitation, etc.) but not the exclusion of any other integer or group of integers. Thus, the term "comprising" as used herein is inclusive or open-ended and does not exclude additional, unrecited integers or method/processing steps.

As used herein, the term "disease" is used to define any abnormal condition that impairs physiological function and is associated with a particular symptom. The term is used broadly to include any disorder, disease, abnormality, condition, disease, disorder, or syndrome in which physiological function is impaired, regardless of the nature of the etiology (or whether the etiological basis for a disease is actually established). Thus, it includes conditions caused by infection, trauma, injury, surgery, radiation ablation, poisoning, or nutritional deficiency.

In the context of the method of securing a device of the invention as defined above, the term subject (which, where the context allows, is to be understood as including "individual", "animal", "patient" or "mammal") defines any subject, in particular a mammal.

Subject, meaning treatment thereof. Mammalian subjects include, but are not limited to, humans, domestic animals, farm animals, zoo animals, sport animals, pet animals (such as dogs, cats, guinea pigs, rabbits, rats, mice, horses, cattle, and the like); primates (such as apes, monkeys, chimpanzees, and chimpanzees, etc.); canines (such as dogs and wolves, etc.); felines (such as cats, lions, tigers, etc.); equine (such as horse, donkey, zebra, etc.); food animals (such as cattle, pigs, and sheep); ungulates (such as deer and giraffes); and rodents (such as mice, rats, hamsters, guinea pigs, and the like). In a preferred embodiment, the subject is a human.

Drawings

The invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

fig. 1 is a perspective view from above and one side of a first embodiment of a medical anchoring device according to the present invention, wherein the medical anchoring device has a medical article attachment portion and a helical anchor or spiral anchor for securely inserting the medical anchoring device into a subject, and securing the medical article to the medical anchoring device and the subject;

FIG. 2 is a perspective view from above and to one side of the underside of the medical anchor device;

fig. 3 is an image viewed from above and to one side of a first medical anchoring device placed on a subject prior to insertion into an insertion site of the subject and a second medical anchoring device inserted into the subject at the insertion site with a helical anchor of the medical anchoring device, the insertion site being defined by a single incision marking visible through a lumen of the medical anchoring device;

fig. 4 is a side image of the medical anchoring device of fig. 3 after insertion, with the outer skin layer partially cut away to reveal a helical anchor anchored in the subcutaneous layer (subcutaneous tissue) of the subject;

fig. 5 is an enlarged image from above of the inserted medical anchoring device of fig. 3 and 4, wherein the incision marker is visible through the lumen;

fig. 6 is a perspective view from below and from one side of a second embodiment of a medical anchoring device according to the invention, wherein the device is provided with a space in the form of a slot-like gap defined by the spacer arms between the medical article attachment portion and the helical anchor for receiving the skin of a subject;

fig. 7 is a perspective view from below and from one side of the medical anchoring device of fig. 6;

fig. 8 is a top view of the medical anchoring device;

fig. 9 is a bottom view of the medical anchoring device;

fig. 10 is a side view of the medical anchoring device;

FIG. 11 is a partially rotated side view of the medical anchoring device, an

Fig. 12 is a fully rotated side view of the medical anchoring device.

Detailed Description

As shown, a medical anchoring device for securing a medical article to a subject is denoted by reference numeral 1 and generally comprises an upper medical article attachment portion 2 for receiving a medical article (such as a catheter, tube, etc.) and a lower insertion portion 3 for subcutaneous insertion into a subject to secure the medical anchoring device 1 to the subject. More specifically, the medical article attachment portion 2 includes a cylindrical platform 4, while the insertion portion 3 includes a generally flat helical anchor 5, the helical anchor 5 having a generally flat helical pitch to prevent drilling into the subject, i.e., the helical anchor 5 is generally in a single plane such that the helical anchor 5 does not drill. Thus, the helical anchor 5 is adapted to enter the skin to a depth of the incision that is typically approximately equivalent to the median skin depth, i.e., the helical anchor is positioned below the dermis layer. Thus, the helical anchor 5 anchors the medical anchoring device 1 of the invention subcutaneously (i.e. below the dermis layer) by spreading the anchoring force in a lateral horizontal plane defined by the helical anchor 5, rather than drilling into the skin at a vertical anchoring force. Thus, the helical anchor 5 (and in particular the elongated body 16) creates and defines a planar or archimedean helical channel in the adipose tissue (hypodermis) below the dermis and epithelium to anchor the medical anchoring device 1 of the invention under the skin. The channel for receiving the elongated body 16 may also be created with a scalpel via an incision, if desired.

In this embodiment, the helical anchor 5 also extends laterally outward from the cylindrical platform 4 to further increase the horizontal anchoring force. The helical anchor 5 is rotatably inserted into the subject in a clockwise or counterclockwise manner as required by the orientation of the helical anchor 5 to secure the medical anchoring device 1 to the subject without over-drilling into the subject, and can be detached from the subject by counter-rotating the medical anchoring device 1.

The cylindrical platform 4 comprises a circular side wall 6, the circular side wall 6 having a bottom edge 7, a top edge 8 and a central lumen 9, the bottom edge 7 being arranged towards the helical anchor 5, the central lumen 9 extending between the bottom edge 7 and the top edge 8, respectively, to define a bottom opening 10 and a top opening 11 in the cylindrical platform 4, such that medical items and devices can pass through the central lumen 9 via the bottom opening 10 and the top opening 11, respectively.

The top edge 8 of the cylindrical platform 4 is provided with a top medical article mount or fitting 12 at the top opening 11 for securing an external medical article to the medical device anchor 1. The top mount or fitting 12 can be shaped or configured as desired depending on the type and size of medical article to be attached to the medical device anchor 1. In this embodiment, the top mount 12 is in the form of a groove 13 defined in the top edge 8, which groove 13 is provided with a thread 14 for attachment to a complementary fitting on the medical article.

Similarly, the bottom edge 7 of the cylindrical platform 4 is provided with a bottom medical article mount or fitting 15 at the bottom opening 10 for securing a medical article (such as an internal catheter or tube) to the medical anchoring device 1.

The spiral anchor 5 of the insertion portion 3 comprises a coiled elongate body 16, the spiral anchor 5 having a medical article attachment portion or platform end 17 attached to the cylindrical platform 4 and a free insertion end 18 for insertion into a subject. More specifically, in this embodiment, the platform end 17 abuts the bottom edge 7 of the cylindrical platform 4, while the coiled elongate body 16 is rolled outwardly from the bottom edge 7 to terminate at an insertion end 18. The length of the coiled elongated body 16 can be sized as desired. The helical anchor 5 may be formed as a clockwise or counterclockwise helix as desired and, as noted above, is generally disposed in a substantially single plane to prevent over-penetration into the subject. Thus, in particular, the arrangement of the elongated body 16 of the helical anchor 5 in a single plane allows for subcutaneous penetration by the helical anchor 5, generally up to a median subcutaneous skin depth or thickness defined by the incision depth, which is sufficient to reversibly anchor the medical anchoring device 1 to the skin of the subject, but not to drill invasively into the subject.

The helical anchor 5 is sufficiently rigid to allow it to rotate in tissue and create a helical channel corresponding to the helix of the helical elongate body 16 so that the helical anchor 5 can enter tissue without over-drilling. In one embodiment, the helical elongate body 16 is also sufficiently compliant or flexible to allow the medical anchoring device 1, and in particular the central lumen 9, to be in a centered position relative to the incision point when fully inserted. More specifically, the flexibility of the elongated body 16 ensures that the incision point is centrally located within the lumen 9 in the fully inserted position. Although the applicant does not wish to be bound by any theory, it is believed that the flexibility of the elongate body 16 allows the helical anchor 5 to be slightly helical/curved downwardly and/or outwardly when in the fully inserted position to anchor the medical anchoring device 1 centrally with respect to the incision point. This allows for easy and unobstructed insertion of the medical device through the incision point.

As shown in particular in fig. 3 to 5, in use, the medical anchoring device 1 may be secured to the body 19 of a subject by creating a subcutaneous incision 20 at an insertion site 21 on the skin 22 of the subject. The insertion end 18 of the helical anchor 5 is then placed into the incision 20, and by gripping and rotating the cylindrical platform 4, the coiled elongate body 16 of the helical anchor 5 is rotated in a substantially single horizontal plane through the subcutaneous layer 23 to embed and anchor the medical device anchor 1 in the subject, typically to a depth determined by the incision. When fully rotated, the cut-out 20 at the insertion site becomes visible through the top opening 11 and the central lumen 9 of the cylindrical platform 4, the cut-out 20 being centrally located with respect to the helically wound elongate body 16 of the helical anchor 5.

A medical article (such as a catheter or the like) may then be inserted through the central lumen 9 and incision 20 at the insertion site 21 as desired.

Thus, the subcutaneously inserted medical anchoring device 1 acts as a platform, and additional components may be added to the medical article attachment portion 2 as needed, depending on the intended therapeutic use or type of medical article employed.

The medical anchoring device 1 of the invention can also be removed simply by rotating the helical anchor 5 in the opposite direction, without the need for invasive surgical intervention, such as that required for prior art retainers or the like, where the suture or the retainer itself must be surgically removed from the subject.

Fig. 6 to 12 show a second embodiment of a medical anchoring device 1 that is substantially similar to the medical anchoring device 1 of fig. 1 to 5, and like reference numerals refer to like parts. As follows, in the present embodiment, the medical anchoring device 1 is provided with a skin-receiving gap 24 between the medical article mounting portion 2 and the helical anchor 5 for receiving the skin between the medical article mounting portion 2 and the helical anchor 5 of the subject. The structure of the gap 24 is slot-like and is defined by the bottom edge 7 of the cylindrical platform 4 and the coiled elongate body 16 of the helical anchor 5. More specifically, the coiled elongate body 16 is spaced from the bottom edge 7 of the cylindrical platform 4 by a downwardly depending spacer arm 25, the spacer arm 25 extending between the platform end 17 of the coiled elongate body 16 and the bottom edge 7 of the cylindrical platform 4 to define the gap 24. Thus, the width of the gap 24 is determined by the size of the spacer arm 25, the spacer arm 25 typically being dimensioned such that the gap 24 can receive a skin layer of medium thickness without damaging or squeezing the skin, i.e. without causing discomfort to the subject. The spacer arm 25, unlike the helical anchor 5, can be formed of a material that is not flexible, and therefore, the spacer arm 25 also serves as a reinforcing spacer arm 25 to reinforce the helical anchor 5 when inserted into a subject.

The spacer arms 25 are further configured to define a concave curved face 26, which concave curved face 26 is disposed inwardly towards the gap 24 between the platform end 17 of the coiled elongate body 16 and the bottom edge 7 of the cylindrical platform 4. The curved face 26 acts as an abutment surface or stop to abut against the skin received in the gap 24 after the medical anchoring device 1 is fully inserted. The concave curved surface 26 also prevents compression of the skin to further enhance comfort for the subject. Furthermore, the applicant has found that the curved surface 26 also enhances the overall strength of the spacer arms 25 and of the medical anchoring device 1 during insertion.

In the present embodiment, the elongated body 16 of the helical anchor 5 is dimensioned to a reduced length when compared to the elongated body 16 of fig. 1 to 5, such that the helical anchor 5 is fully inserted after one full rotation of the medical anchoring device 1, thereby further reducing the invasive force of the device 1.

Further, in the present embodiment, the circular side wall 6 of the cylindrical platform 4 is shaped to define a waist 27 to provide a secondary medical article mount or fitting on the cylindrical platform 4.

The medical anchoring device 1 of the invention may be formed of any suitable material or combination of materials, for example. For example, the helical anchor 5 may be formed of a resilient or elastomeric material having a desired degree of flexibility, such as Santoprene (trade mark), while the leg 25 and/or medical article attachment portion may be formed of a non-resilient or less resilient material.

The medical anchoring device 1 may also be dimensioned as required according to the size and/or level of support required for the medical article to be attached to the medical anchoring device 1. For example, in the case of a medical anchoring device 1 for supporting a catheter, the medical anchoring device of fig. 6 to 12 may be dimensioned such that the distance between the legs 25 and the diametrically opposite bottom edges 7 of the cylindrical platform 4 corresponds to the incision length normally used for the insertion of catheters, for example between about 10mm and about 20 mm.

Although the medical anchoring device 1 of the present invention may be formed as a single medical anchoring device 1, i.e. a single unit, the medical anchoring device 1 may also be formed as a multi-part device if desired, for example, the medical anchoring device 1 can be made up of two or more parts (such as the medical attachment portion 2) connectable to the lower insertion portion 3.

The medical anchoring device 1 may also form part of a medical anchoring system according to the invention, comprising the medical anchoring device 1 and a medical article (such as a catheter or the like engageable with the medical anchoring device 1).