ZA200907140B

ZA200907140B - A haemostatic clamp

Info

Publication number: ZA200907140B
Application number: ZA200907140A
Authority: ZA
Inventors: Nicolas Kairinos
Original assignee: Univ Cape Town
Priority date: 2008-07-23
Filing date: 2009-07-23
Publication date: 2010-06-30

Description

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A HAEMOSTATIC CLAMP

FIELD OF THE INVENTION

This invention relates to a haemostatic clamp for use on a lip, particularly during surgery on a lip.

BACKGROUND TO THE INVENTION

The highly vascular nature of lips results in excessive bleeding when this tissue is cut either traumatically or surgically. This makes visualisation and suturing of the tissues difficult until haemostasis has been achieved.

Haemostasis can be achieved by pressure application, electrocautery or by : infiltrating the tissue with a solution containing adrenalin.

Although applying pressure may be effective following trauma, this technique is not appropriate during surgery as it is time consuming and may not help with larger arterial vessels. Electrocautery of vessels can also be difficult at times as this device does not work well in conditions where there is excessive bleeding. Often there are no specific vessels causing the bleeding, as the muscle itself has a very rich blood supply which continues to ooze. Extensive electrocautery of this muscle has the disadvantage of causing excessive necrotic tissue, which can induce scar tissue or result in -post-operative : infection.

A common technique is to infiltrate the lip with a local anaesthetic mixture containing adrenalin. The adrenalin results in vasoconstriction which stems bleeding to some degree. The disadvantages of this are that there is still some amount of bleeding that persists and more importantly tissue architecture is distorted by the volume of infiltrate. The latter is of particular

P1858ZA00/Kairinos Lip Clip Complete importance in lip surgery as perfect alignment of structures is imperative.

Malalignment of less than 1 mm can be easily noticed once wounds have healed and may require revision surgery. To circumvent this problem surgeons often mark specific landmarks with a surgical marking pen prior to infiltrating. These marks often get erased, however, during the surgical skin preparation or by continuous wiping of blood intra-operatively.

Surgeons often require an assistant during lip surgery in order to swab blood and also to hold the lip in a desired position to facilitate the placement of sutures. The latter is particularly necessary when repairing the inner mucosal layers of the lip.

Unlike an upper arm tourniquet, which allows for a bloodless field during hand surgery, there are currently no tourniquets that can be used for facial surgery as they cannot be placed around the neck for obvious reasons.

There are no commercially available devices that can hold the lip in a position desirable for suturing. US patent 4,467,803 discloses a haemostatic clamp for use with the lips and the mucosal side of the cheek. The device disclosed includes long handles with a screw mechanism to cause a set of jaws to clamp over the lip. These handles are cumbersome and may provide an obstruction to the surgeon. Also, this device is not intended to be disposable which is a considerable disadvantage considering that many lips are sutured in the casualty area of clinics and day hospitals. Furthermore, two people will typically be required to use the device; a first person to insert it over a lip and’ hold it in position, and a second to operate the pair of screws to apply tension to the jaws.

P1858ZA00/Kairinos Lip Clip Complete

OBJECT OF THE INVENTION

It is an object of this invention to provide a haemostatic clamp which will at least partially alleviate some of the abovementioned problems.

SUMMARY OF THE INVENTION

In accordance with this invention there is provided a haemostatic clamp comprising a pair of jaws each forming a U-shape having a web and a pair of sides, and configured to fit over a lip with the web of one jaw adjacent the gums and the distal end of each side adjacent the edge of the lip with part of the edge of the lip exposed between the sides of the jaws, and operable to apply sufficient pressure to the lip between adjacent surfaces of the jaws to cause substantial haemostasis in the portion of the lip between the jaws.

Further features of the invention provide for the sides of the jaws to be joined distally from the webs thereof; for the adjacent surfaces of the jaws to be generally flat, preferably having a width of about 5mm or alternatively for the jaw to have a convex cross-sectional shape of said adjacent surfaces; for the surface of at least one jaw adjacent to the other jaw to be roughened; for the sides of the jaws to be more widely spaced apart distally from the webs than along the remainder of their length to accommodate thickening of the edge of the lip; and for the webs to be curved outwardly and towards the distal ends of the sides.

Still further features of the invention provide for one or more legs to be provided on at least one jaw to be engageable with a tooth or gum to cause the clamp with the lip secured therein to project away from the mouth; for the or each leg to be movably secured to the jaw; and for the or each leg to include notches to facilitate engagement with the tooth or gum.

P1858ZA00/Kairinos Lip Clip Complete :

According to one aspect of the invention there is provided for the jaws to be integrally joined and biased towards each other.

According to a second aspect of the invention there is provided for the jaws to 5 be secured together through a hinge, with means provided for limiting movement of the jaws away from each other.

According to a third aspect of the invention there is provided for an inflatable bag to be provided on at least one jaw operable to expand in at least the direction of the opposite jaw.

Further features according to this aspect of the invention provide for the bag to be inflatable through a valve with a gas, liquid or gel; and for valve to be operable to permit the bag to be deflated.

The invention also provides an applicator tool for operating a haemostatic clamp as defined above comprising a pair of applicator jaws operated by a pair of applicator handles extending from each other such that movement of the handles towards each other causes the applicator jaws to move apart, and wherein the applicator jaws are shaped to engage each jaw of the clamp.

Further features of the invention provide for each of the applicator jaws of the tool to include a flat surface shaped to cooperate to exsanguinate a lip during installation of a clamp thereover.

The invention further provides a method of achieving haemostasis in part of a lip which includes exsanguinating part of the lip and applying a haemostatic clamp substantially as defined above thereover.

In order that the invention may be more fully understood, examples of the invention will now be described with reference to the accompanying drawings.

P1858ZA00/Kairinos Lip Clip Complete .

BRIEF DESCRIPTION OF THE DRAWINGS

) In the drawings:-

Figure 1 is a perspective view of a first embodiment of a haemostatic clamp;

Figure 2 is a front elevation of the clamp in Figure 1 in use on a lip;

Figure 3 is a perspective view of a tool for operating the haemostatic : clamp in Figure 1;

Figure 4 is a perspective view of a second embodiment of a haemostatic clamp; :

Figure 5 is a perspective view of a third embodiment of a haemostatic clamp;

Figure 6 is a perspective view of a fourth embodiment of a haemostatic clamp;

Figure 7 is a perspective view of a fifth embodiment of a haemostatic clamp; and,

Figure 8 is a perspective illustration of an alternative applicator tool and haemostatic clamp with the forward part of the clamp cut - away to reveal the jaws more clearly.

DETAILED DESCRIPTION WITH REFERENCE TO THE DRAWINGS

:

A haemostatic clamp (1) is shown in Figure 1 and includes a pair of jaws (2, 3) each provided by an elongate element formed into a U-shape with a web (5, 6)

P1858ZA00/Kairinos Lip Clip Complete :

and a pair of sides (8, 9). The jaws (2, 3) may be moulded from a resiliently deformable plastics material or they may be fabricated by forming a suitable pre-prepared section to the required shape. In either event, the ends (11) of the sides (8, 9) distal from the webs (5, 6) are joined through an integral radiused joint (13) which holds the jaws (2, 3) spaced slightly apart from each other.

The webs (5, 6) are curved upwardly towards the distal ends (11) of the sides (8, 9) and outwardly to conform roughly to a typical jaw line (not shown).

The adjacent surfaces (14, 15) of the jaws (2, 3) are preferably generally flat and have a width of approximately 5mm. These surfaces (14, 15) are also textured to provide resistance to slipping. It is to be mentioned, however, that in tests conducted to date, for purposes of production of suitable prototypes, generally circular cross-sectioned jaws have been formed and tested.

The joints (13) have a somewhat bulbous shape in elevation which results in the sides (8, 9) being more widely spaced apart adjacent the joints (13) than along the remainder of their length.

In use, as shown in Figure 2, the haemostatic clamp (1) is secured over a lip (20) by separating the jaws (2, 3), inserting part of the lip (20) therebetween until the edge (22) of the lip (20) abuts the joints (13), and then releasing the jaws (2, 3). In this condition, the web (6) of the one jaw (3) is adjacent the gums. The bias towards each other provided by the shape and material of the jaws (2, 3) is sufficient to cause haemostasis in the portion of the lip (20) between the jaws (2, 3). Tests conducted to date indicated that a force of “about 20 Newtons should operate effectively. Under these conditions a cut (24) in the lip (20) can easily be sutured by a single person with little assistance from other personnel.

P1858ZA00/Kairinos Lip Clip Complete

The bulbous shape of the joints (13) assists in accommodating the thickening at the edge (22) of the lip normally identified with the vermillion or red part thereof. This avoids applying excessive pressure to the edge (22) which could cause damage to the tissue.

The textured surface (14, 15) of the jaws (2, 3) assists in preventing the haemostatic clamp (1) from slipping out of position, particularly on the inner mucosal surface of the lip (20) which can be very slippery. The thickness of the jaws is also selected to prevent excessive tissue pressure and the possibility of tissue damage.

As shown in Figure 3, an applicator tool (30) can be provided to assist in operating the jaws (2, 3). The tool (30) may have a pair of hinged arms (32) with handles (34) at one end and an inclined, bifurcated applicator jaw (36) at the opposite end, each terminating in a flat tine (38). A pair of slots (40) is provided in the web (5, 6) of each jaw (2, 3) of the clamp in which the flat tines (38) locate.

The arms (32) are hingedly secured in such a manner that movement of the handles (34) towards each other causes the applicator jaws (36) to move apart. With the tines (38) engaged in the slots (40) in the jaws (2, 3) of the haemostatic clamp, the handles (34) are simply moved together to cause the applicator jaws and jaws of the haemostatic clamp to open whereafter the ~ haemostatic clamp (1) can be inserted over a lip (20) as described with reference to Figure 2. The inclination of the applicator jaws (36) to the arms facilitates insertion into the patient's mouth. Once in position, the handles (34) are released allowing the jaws (2, 3) of the haemostatic clamp to move together under their own bias and the tines (38) are then withdrawn from the slots (40).

If desired, a flat surface could also be provided on each of the applicator jaws between which the lip can be squeezed to cause exsanguination of the lip

P1858ZA00/Kairinos Lip Clip Complete during installation of the haemostatic clamp (1). Such an arrangement is illustrated in the embodiment of the invention illustrated in Figure 8. In that arrangement, the applicator tool (100) has a pair of handles (102) operable as described above and a pair of generally flat applicator jaws (103) at the opposite ends of the arms (104). The leading edges of the applicator jaws have a rebate (105) extending therealong so as to accommodate the co- operant jaw (103) of the haemostatic clamp (107).

The two flat surfaces are designed such that the haemostatic clamp can easily slid onto them with the rebate receiving the jaws of the haemostatic in a manner that prevents them from sliding off. Opening the applicator jaws of the applicator tool therefore opens haemostatic clamp and separates the flat surfaces of the applicator jaws. As the applicator jaws are allowed to move together during installation of the haemostatic clamp, they automatically exsanguinate the lip until the haemostatic clamp is in its installed position. A gentle force applied by the surgeon enables the applicator tool to be disengaged from the haemostatic clamp. In order to remove the haemostatic clamp a reverse procedure is employed with only a relatively small force being necessary to introduce the narrow leading edges of the flat applicator jaws between the lip and haemostatic clamp.

The haemostatic clamp (1) is highly effective in use, can be easily and cheaply manufactured and, with suitable design, provides substantially unhindered access to a lip to which it is attached.

It will be appreciated, however, that many other embodiments of haemostatic clamp exist which fall within the scope of the invention. For example, as shown in Figure 4, the jaws (40, 42) can be secured together through hinges (44), each provided by a pair of disks (46) secured to the respective sides (48, 49) and rotatable about a pin (61) with the adjacent surfaces of the disks (46) textured to provide resistance to movement of the jaws (40, 42). The texturing

P1858ZA00/Kairinos Lip Clip Complete could take the form of radially extending spines on each of the adjacent surfaces.

Referring to Figure 5, varying lip thicknesses can also be accommodated by providing a hinge (60) in each side (62) of a jaw (64) intermediate the web (66) and joint (68). The hinges (60) also encourage an even distribution of pressure between the sides (62) of the jaw (64).

Referring to Figure 6, a pair of arms (80) can be provided on the web (82) of one jaw (84) movable to extend normally to the plane of the jaw (84).

Extending the arms (80) permits them to engage the teeth (not shown) and so cause the haemostatic clamp (85) with a lip secured therebetween to be directed away from the mouth to facilitate access thereto. The arms could, however, have any suitable configuration, location and means of attachment to the jaws.

It is not required that the jaws necessarily be movable with respect to each other. For example, as shown in Figure 7, an inflatable bag (90) can be provided on the adjacent surfaces of either or both of the jaws (92, 93). In this embodiment the bag (90) is only provided on one jaw (92). Inflating the bag causes it to expand in the direction of the opposite jaw (93) thus applying pressure to tissue located between the jaws. A valve (95) can be provided which is connectable to a syringe (97) and permits the bag to be inflated with air, water or any other suitable fluid. In this embodiment the valve (95) is located on one side of the bag (90) but it could be located in any convenient

X location. It could even be attached to the end of a flexible tube connected to the bag (90) in similar fashion to that of an endotracheal tube's inflatable cuff.

Such an inflatable bag permits a user selectable amount of pressure to be applied and also assists in accommodating varying lip thicknesses and profiles. :

P1858ZA00/Kairinos Lip Clip Complete

Any suitable material can be used in the construction of the haemostatic clamp including a transparent material which facilitates a better visual perspective of the entire lip. Where it is desired that the haemostatic clamp be reusable, it will be preferable to use a stainless steel. It is also considered to be appropriate to manufacture the haemostatic clamp of a metal having spring qualities or a metal alloy which retains memory such as shape memory alloys particularly when exposed, for example, to particular temperatures. One such alloy that may exhibit suitable properties is a nickel-titanium alloy.

Also, any suitable means of opening the jaws can be used. For example, arms could be provided on the jaws which pivot about the hinges to permit opening of the jaws. Furthermore, any suitable means of biasing the jaws together can be used, including spring- or clip-like elements over or between the jaws. :

P1858ZA00/Kairinos Lip Clip Complete

Claims

CLAIMS:

1. A haemostatic clamp comprising a pair of jaws each forming a U-shape having a web and a pair of sides, and configured to fit over a lip with the web of one jaw adjacent the gums and the distal end of each side adjacent the edge of the lip with part of the edge of the lip exposed between the sides of the jaws, and operable to apply sufficient pressure to the lip between adjacent surfaces of the jaws to cause substantial haemostasis in the portion of the lip between the jaws.

2. A haemostatic clamp as claimed in claim 1 in which the sides of the jaws are joined distally from the webs thereof.

3. A haemostatic clamp as claimed. in either one of claims 1 or 2 in which the adjacent surfaces of the jaws are generally flat.

4, A haemostatic clamp as claimed in either one of claims 1 or 2 in which the jaws have a convex cross-sectional shape of said adjacent surfaces.

5. A haemostatic clamp as claimed in any one of the preceding claims in which the surface of at least one jaw adjacent to the other jaw is roughened. :

6. A haemostatic clamp as claimed in any one of the preceding claims in which the sides of the jaws are more widely spaced apart distally from the webs than along the remainder of their length to accommodate thickening of the edge of the lip.

7. A haemostatic clamp as claimed in any one of the preceding claims in which the webs are curved outwardly and towards the distal ends of the sides. P1858ZA00/Kairinos Lip Clip Complete

8. A haemostatic clamp as claimed in any one of the preceding claims in which one or more legs are provided on at least one jaw to be engageable with a tooth or gum to cause the clamp with the lip secured therein to project away from the mouth.

9. A haemostatic clamp as claimed in claim 8 in which the or each leg is movably secured to the jaw.

10. A haemostatic clamp as claimed in any one of the preceding claims in “which the jaws are integrally joined and biased towards each other.

11. A haemostatic clamp as claimed in any one of claims 1 to 9 in which the jaws are secured together through a hinge, with means provided for limiting movement of the jaws away from each other.

12. A haemostatic clamp as claimed in any one of claims 1 to 9 in which an inflatable bag is provided on at least one jaw operable to expand in at least the direction of the opposite jaw to effect a clamping action.

13. A haemostatic clamp as claimed in claim 12 in which the bag is inflatable through a valve with a gas, liquid or gel.

14. An applicator tool for operating a haemostatic clamp as claimed in any one of claims 1 to 11 comprising a pair of applicator jaws operated by a pair of applicator handles extending from each other such that movement of the handles towards each other causes the applicator jaws to move apart, and wherein the applicator jaws are shaped to engage each jaw of the haemostatic clamp.

15. An applicator tool as claimed in claim 14 in which each of the applicator jaws of the tool includes a flat surface shaped to cooperate to exsanguinate a lip during installation of a haemostatic clamp thereover. P1858ZA00/Kairinos Lip Clip Complete ’

16. A haemostatic clamp substantially as herein described and exemplified with reference to Figures 1 and 2 of the accompanying drawings; or with reference to any one of Figures 4, 5, 6, or 7 of the accompanying drawings.

17. An applicator tool substantially as herein described and exemplified with reference to either Figure 3 of the accompanying drawings, or with reference to Figure 4 of the accompanying drawings. Dated this 13" day of October 2009 VON SEIDELS Intellectual Property Attorneys for the applicant P1858ZA00/Kairinos Lip Clip Complete :