The present invention relates to a surgical instrument placement tool for holding tools for angiographic procedures in the fields of invasive radiology, vascular surgery and cardiology.
It also relates to a tool holder for holding tools for angiographic procedures in the fields of invasive radiology, vascular surgery and cardiology in case a surgical team operates at a table of extra length.
In addition, it relates to a pack of such tool holders.
The use of catheters, spring guides wires, balloons and stents is increasing rapidly in the fields of invasive radiology, vascular surgery and cardiology. Millions of procedures are carried out every year throughout the world, as there is increasing tendency to treat vascular diseases with endovascular techniques. This is especially prominent in the field of vascular surgery, where there is an increasing tendency to choose endovascular methods for first line treatments.
The endovascular instruments are mainly introducers, catheters, spring guide wires, stents and balloons. There are many types of tools in different length and diameter from several centimetres to 3 meters in length. In the majority of procedures, at least 7-8 tools are used and in many others 10-20 tools and more.
To obtain safe access to blood vessels and other hollow organs, the Seldinger technique is a medical procedure often used. It is named after Dr. Sven-Ivar Seldinger, a Swedish radiologist, who introduced the procedure in 1953.
The desired vessel or cavity is punctured with a sharp hollow needle called a trocar, with ultrasound guidance if necessary. A round-tipped spring guide wire is then advanced through the lumen of the trocar, and the trocar is withdrawn. After enlarging the cutaneous puncture with a scalpel, a blunt dilator can now be passed over the guide wire into the cavity or vessel. Then, the tip of a catheter is threaded into the vessel using the spring guide wire. After advancing the catheter into final dwelling position, the spring guide wire is withdrawn.
The endovascular tools are sterile and due to their flexibility and length it is a problem to hold them in one place without making them non-sterile (“they have their own life”). They fall or become non-sterile often. They are hard to handle by one person and hold in an appropriate way. Their cost is very high and a loss of such tools in a procedure has economic implications. Due to their flexibility and length, the operator needs more assistants and it is sometime challenging to handle the tools. Often two to three persons are needed to hold a long catheter/wire.
Most of the labs/angio suites/operation rooms put those tools on a simple table when they are not in use. This obviously does not solve the problem. Some nurses put the wires back to their magazine (time consuming and non practical solution).
There is a real need to have a solution in a form of some placement tool to keep those instruments in their place i.e. that may free some hands (nurse/assistant) and may avoid the falling of a tool or its becoming non-sterile. It is of highest importance in acute procedures. Presently, there are no such placement tools.
U.S. Pat. No. 4,476,860 discloses surgical drapes having a plurality of pockets facing one another for retaining surgical instruments. U.S. Pat. No. 5,010,899 discloses a surgical drape have a plurality of loops for maintaining medical devices during the procedure. U.S. Pat. No. 5,464,025 discloses a self-contained surgical tubing management system where all of the required surgical hand pieces and power and fluid tubing, cables and connections are incorporated in a single disposable package. The system includes a sterile sheet that covers at least a portion of the patient's body, and has pockets and fasteners that contain and position the instruments, so that they are easily accessible during the operation process. None of these meet existing needs in a satisfactory manner.
The main object of the present invention is to provide a surgical instrument placement tool for holding tools for angiographic procedures in the fields of invasive radiology, vascular surgery and cardiology.
That object is achieved in accordance with the present invention in that the placement tool comprises:
Thanks to the vertical double curvature bottom surface, especially in combination with the plurality of tool holders such a placement tool will keep the often very long and springy endovascular instruments in their place. This will free some hands (nurse/assistant) and will avoid the falling of a tool or its becoming non-sterile.
To facilitate the use of long springy instruments, the pouch member may project horizontally beyond the feet of the lying average sized patient. A suitable size of the projection of the pouch member is on the order of half a meter, and then the double curvature bottom surface has a horizontal diameter on the order of half a meter.
Preferably, an arcuate member is located in the pouch member for maintaining the shape of the double curvature bottom surface.
The arcuate member suitably has two end portions extending horizontally between the spread legs of the lying average size patient, and the surgical drape has two pockets for receiving and holding at least the very ends of said end portions. By balancing the weight of the end portions against the combined weight of the pouch member and the arcuate central portion of the arcuate member, the pouch member will project horizontally in cantilever fashion from the foot end of the surgical table.
To hold the long springy instruments and other surgical tools safely without preventing them from being moved in their longitudinal direction, the tool holders suitably are substantially comb-shaped but have comb teeth that are thicker at their tips than at their roots, so that the space between the teeth is smaller at the tips than at the roots.
The tool holders preferably are made of rubber or similar elastic material. As the teeth tips on both sides of the space will be pressed away from each other on insertion of the long springy instruments and other surgical tools in the tool holders, it will be easy to mount the instruments in the tool holders and they will be retained therein. A single-hand grip is sufficient for inserting them into the tool holder and removing them there from.
Since in a majority of procedures at least 7-8 tools are used, the number of spaces between the comb teeth suitably is on the order of ten.
To facilitate the mounting of the long springy instruments and other surgical tools in the tool holders and later handling of them, at least some of the spaces between the teeth of the tool holders may be color coded.
Preferably, the tool holders are attached to the surgical drape by tape having adhesive on both sides.
The upwardly exposed interior surface of the surgical drape may be marked with recommended locations for attaching the tool holders so as to facilitate the attachment at optimum locations.
In addition to said foot end, the surgical drape has an opposed upper end, and to fix the placement tool to the patient, the upper end has one side of a piece of tape having adhesive on both sides adhered thereto, the other side carrying a removable protective film for adhering the placement tool to the patient.
To securely hold the placement tool to the patient, the length of the tape at the upper end of the surgical drape may be sufficient to extend a width across the patient of 30-50 cm (12-20 in.). If desired, the upper end of the surgical drape may have a wing extending toward a nave of the patient.
To be soft, tight and strong, the surgical drape is made from a laminate having a middle layer of plastic film covered by fibrous surface layers.
Also the pouch member should be soft, tight and strong and is made from a laminate having a middle layer of plastic film covered by fibrous surface layers. The plastic film preferably is reinforced by embedded fibers to facilitate the maintaining of the shape of the pouch member. Alternatively or additionally, one or more stiffening members may be provided in or bonded to the laminate pouch member to assist in maintaining its desired shape. With plastics in the pouch member, it can be attached to the surgical drape be welding.
Another object of the present invention is to provide tool holder for holding tools for angiographic procedures in the fields of invasive radiology, vascular surgery and cardiology in case a surgical team operates at a table of extra length.
That object is achieved in accordance with the present invention in that the tool holder is substantially comb-shaped but has comb teeth that are thicker at their tips than at their roots, so that the space between the teeth is smaller at the tips than at the roots, and that the tool holder has a back side having one side of a piece of tape having adhesive on both sides adhered thereto, the other side carrying a removable protective film for adhering the tool holder to any useful surface, such as an ordinary sterile drape.
Thanks to the use of at least one tool holder, it will be easier to maintain the often very long and springy endovascular instruments in their place. This will free some hands (nurse/assistant) and will assist in avoiding the falling of a tool or its becoming non-sterile.
As disclosed above, the tool holder preferably is made of an elastic material, the number of spaces between the comb teeth is on the order of ten, and suitably at least some of the spaces between the teeth of the tool holders are color coded.
If the tool holders are acquired separately and not as included in the surgical instrument placement tool of the invention, a pack containing four tool holders appears to satisfy most requirements. Four tool holders can easily be positioned so as to permit the long springy instruments to form a loop, in which they are movable in their longitudinal direction but yet maintained comparatively safe in the tool holders.
In the following, the invention will be described in more detail with reference to preferred embodiments and the appended drawings.
The placement tool 1 comprises:
As shown in
The generally horizontal upwardly exposed bottom surface 27 of the pouch member 20 extends substantially in the same plane as the plane of the upwardly exposed, generally horizontal, lower surface 13 of the surgical drape 10. The back of the lower surface 13 of the surgical drape 10 normally rests directly on the upper surface of the surgical table 3, i.e. positioning the exposed surfaces 13, 27 generally in level with the top face of the surgical table 3. In the embodiment shown the lower surface 13 of the surgical drape 10 is integrated with leg covering portions 17, which form upwardly extending, inner side walls 17′ that partly surrounds the lower surface 13, to form a practical space for placement of tools. In a similar manner the pouch member 20 also presents a space for placement of tools (if desired) within that area thereof, that is exposed within that is positioned centrally in relation to the edge 22 of the wall member 28. Thanks to forming the wall member 28 presenting a vertical double curvature bottom surface 21 the sometimes very long and springy surgical instruments are hindered from escaping out away from the working space, i.e. the space surrounded by the leg portions 17 of the drape 10 and the wall 28 of the pouch. This will free some hands (nurse/assistant) and will avoid the falling of a tool or its becoming non-sterile. Furthermore the walls 17′, 28 may preferably be arranged such that they totally surround the placement areas 13,27, whereby liquids are hindered from escaping.
The double curvature bottom surface 21, has a first curvature with a relatively large radius r1, that forms a U-shape of the inner surface 21 of the wall 28 (and since all parts of the wall 28 have substantially the same thickness also the outer periphery is U-shaped, as seen from above in
In
In the embodiment shown in
In the preferred embodiment shown in
The tool holders 30-31′ preferably are made of rubber or similar elastic material, more preferred of a porous kind which will decrease weight and cost. As the tooth tips 33 on both sides of the space 35 will be pressed away from each other on insertion of the long springy instruments 4 and other surgical tools in the tool holders 30-31′, it will be easy to mount the instruments 4 in the tool holders 30-31′ and they will be retained therein. A single-hand grip is sufficient for inserting them into the tool holder 30-31′ and removing them there from.
In some procedures, 10-20 tools and more are used, but since in a majority of procedures at least 7-8 tools are used, the number of spaces 35 between the comb teeth 32 suitably is on the order of ten.
To facilitate the mounting of the long springy instruments 4 and other surgical tools in the tool holders 30-31′ and the later handling of them, at least some of the spaces 35 between the teeth of the tool holders 30-31′ may be color coded (not shown).
Preferably, the tool holders 30-31′ are attached to the surgical drape 10 by tape (not shown) having adhesive on both sides, but if desired it is, of course, possible to use some other attachment method.
The upwardly exposed interior surface of the surgical drape 4 may be marked with recommended locations for attaching the tool holders 30-31′ so as to facilitate the attachment at optimum locations. In the drawings, the optimum locations are not shown separately, but in most cases, the positions shown in
In addition to said foot end 12, the surgical drape 10 has an opposed upper end 11. To fix the placement tool 1 to the patient 2, the upper end 11 has one side of a piece of tape 15 having adhesive on both sides adhered thereto, the other side carrying a removable protective film, not shown, for adhering the placement tool 1 to the patient 2 after removal of the protective film
To securely hold the placement tool 1 to the patient, the length of the tape 15 at the upper end 15 of the surgical drape 10 may be sufficient to extend a width across the patient of 30-50 cm (12-20 in.). If desired, the upper end 11 of the surgical drape 10 may have a wing 16 extending toward a nave of the patient 2. The wing 16 may carry an instruction (not shown), if desired, as to direction when preparing the patient on the surgical table for surgery.
To be soft, tight and strong, the surgical drape 10 preferably is made from a flexible laminate e.g. of a kind that is known per se and used already as surgical drapes, having a middle layer of plastic film covered by fibrous surface layers. As an example, the film may be a liquid-impermeable polyethylene film, the top fibrous surface layer may be of a liquid-absorbent nonwoven material, and the bottom fibrous surface layer facing the patient 2 may be of cellulose wadding or the like to enhance patient comfort by absorbing perspiration and preventing direct contact of the patient's skin with the plastic film. However, to provide the desired functionality many other combinations of layers and materials therein are possible.
Also the pouch member 20 should be soft, tight and strong and is made from a flexible laminate. The laminate used here will not come into contact with the patient's skin, so the bottom layer of cellulose wadding or the like may not be needed. Thus, the laminate used in the pouch member 20 may have a bottom layer of plastic film covered by a fibrous surface layer. As in the surgical drape 10, the film may be a liquid-impermeable polyethylene film, and the top fibrous surface layer may be of a liquid-absorbent nonwoven material or a woven fabric. For many applications it is preferred to use the same laminate in the pouch 20 as in the drape 10, e.g. to produce them more or less as an integrated unit. However, to arrange for maintaining a desired shape of the pouch member 20, the laminate, e.g. by integration into the plastic film may be reinforced by embedded fibers, e.g. glass fibers or a woven polyester fabric, to facilitate the maintaining of the shape of the pouch member. Alternatively or additionally, one or more stiffening members 26 may be provided in or bonded to the laminate pouch member 20 to assist in maintaining its desired shape. Furthermore it is foreseen that the desired shape may be created by punching and gluing of the laminate (preferably having some resiliency) to form the desired shape and strength.
In the embodiment shown in
If an arcuate member 23 is used and the stiffening members 26 are located on the interior side of the bottom surface 21 of the pouch member 20, the stiffening members 26 may be shaped, in an embodiment not shown, to provide attachment points, for the arcuate member 23. Such attachment points may be formed as simple shallow recesses or as more complicated snap connections. Further it is foreseen that the arcuate member 23 and stiffening members are integrated to form a unit which may provide the desired shape of flexible drapes 10 and pouches 20, upon introduction thereof. Hence in such an embodiment it may be preferred to have the drape/pouch 10/20 disposable, but the arcuate member/stiffening member 23/26 reusable (hence in a material facilitating sterilization)
A preferred laminate for the pouch member 20 is a traditional kind for surgical drapes. However, to provide the desired functionality, inter alia sufficient strength and flexibility, many other combinations of layers and materials therein are possible. The plastic film in the pouch member 20 may be useful not only for tightness purposes but makes it possible to attach the pouch member 20 to the surgical drape 10 by welding.
The most important field of the surgical instrument placement tool, the separate tool holders and the pack thereof in accordance with the present invention is endovascular surgery and invasive radiology but even invasive cardiology. Both peripheral and central vascular procedures benefit from this tool, and both time and money in these procedures will be saved. Endovascular surgery is performed by radiologists, neurologists, neurosurgeons, cardiologists, and vascular surgeons. The field is rapidly growing as its minimally invasive techniques offer an immediate advantage over more traditional, yet highly invasive surgeries.
The invention is not limited to what has been described above but maybe be varied within the scope of the appended claims. For instance, it is evident that the main function of the invention, i.e. the ability to hinder catheters and other long instruments to fall out/on to the floor, is obtained also without any tool holders positioned on to the drape and/or pouch. Furthermore it is evident that the material of the drape and/or pouch may vary within wide frames to fulfill the desired basic functionality and that different properties may be achieved by alternate laminate/s and/or the manner of combining laminates and/or the manner of gluing the laminates and/or the manner of attaching support members, etc. For instance it is evident that by the use of gluing of layers on to each other and by varying the mounting glue and the amount of layers that are glued to each other, varying properties may be achieved, e.g. to adapt to different needs for different kind of applications. Furthermore it is evident that also the tool holders may be made in a big variety of different materials, e.g. depending on need and/or desires and/or different standards, and/or different requirements regarding different possible aspects. For instance, one aspect that, at least in some parts of the world, is getting more and more of attention is the environmental aspect, Hence an evident alternative regarding the invention is to use materials that are biologically decomposable, as are many fiber products and indeed also polymers of today. In a preferred embodiment all of the parts of the invention should be disposable and in such a case it would of course be an advantage to also have all parts produced in such environmental friendly materials. Furthermore it is evident that to achieve a desired strength to hold the pouch in an essential horizontal position many other means may be used than the above described support device 23, e.g. a flat relatively thick portions in the bottom layer of the drape and pouch. Moreover, it is evident that the leg portions 17 of the drape, do not have to reach all over the legs (as shown in the figures), but that in some applications/situations it is sufficient to merely provide the inner portions 17′ (e.g. combined with tape to keep them in place).
Number | Date | Country | Kind |
---|---|---|---|
0950607-2 | Aug 2009 | SE | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
---|---|---|---|---|
PCT/SE2010/050896 | 8/19/2010 | WO | 00 | 5/14/2012 |