阅读说明：本技术 用于内窥镜相机的盖布以及容器 (Drape for endoscopic camera and container ) 是由 A·卡拉夫雷佐斯 L·卡拉夫雷佐斯 P·克劳斯 于 2019-08-09 设计创作，主要内容包括：本发明涉及一种装置,所述装置包括用于覆盖外科手术器材的管状盖布,并且还包括容器,该容器适于容纳以环形处于轴向压缩状态下的盖布的大部分,该容器包括第一片材和第二片材,其中第一片材和第二片材相对地布置,第一片材具有第一开口,第二片材具有第二开口,其中第一开口被构造成用于从容器中抽出盖布,其中第一开口和第二开口被构造成用于使待覆盖的外科手术器材穿过,其中被容纳的环形盖布部分具有对装置的整体刚度做出主要贡献的机械刚度。本发明还涉及一种用于制造包括管状盖布和容器的装置的方法。(The present invention relates to an apparatus comprising a tubular drape for covering surgical equipment, and further comprising a container adapted to receive a majority of the drape in an annular form in an axially compressed state, the container comprising a first sheet and a second sheet, wherein the first and second sheets are oppositely arranged, the first sheet having a first opening and the second sheet having a second opening, wherein the first opening is configured for withdrawing the drape from the container, wherein the first and second openings are configured for passing surgical equipment to be covered, wherein the received annular drape portion has a mechanical stiffness that mainly contributes to the overall stiffness of the apparatus. The invention also relates to a method for manufacturing a device comprising a tubular drape and a container.)

1. An apparatus, comprising:

a tubular drape for covering the surgical equipment; and

a container adapted to contain a majority of the drape in an annular form in an axially compressed state;

wherein the container comprises a first sheet and a second sheet, wherein the first sheet and the second sheet are oppositely disposed, the first sheet having a first opening and the second sheet having a second opening, wherein the first opening is configured for withdrawing the drape from the container, and wherein the first opening and the second opening are configured for passing surgical equipment to be covered; and is

Wherein the received annular drape portion has a mechanical stiffness that contributes primarily to the overall stiffness of the apparatus.

2. The device of claim 1, wherein the container opens radially inward.

3. The device of claim 1 or 2, wherein the container has an annular dispensing opening.

4. The apparatus of claim 3 wherein the annular dispensing opening is formed between the exterior of the inner core of the container and the inner periphery of the dispensing lip of the outer container component.

5. The apparatus of any one of the preceding claims, wherein the drape is made of a film material and/or a fabric material, and wherein the received drape portion is folded in an axial direction and/or the received drape portion is padded to form a ring.

6. The apparatus of any of the preceding claims, wherein the received annular drape portion defines an axis, wherein the opening of the received annular drape portion is configured to pass the surgical equipment therethrough, and wherein the opening of the received annular drape portion, the first opening, and the second opening are substantially aligned relative to the axis.

7. The device of any one of the preceding claims, wherein the first sheet comprises a dispensing lip at an edge region of the first opening, and an attachment portion radially outward of the dispensing lip, and wherein the first sheet is connected to the second sheet at the attachment portion.

8. The apparatus of any one of the preceding claims, wherein a first end of the drape is attached to the container and/or is located inside the container, and wherein another end of the drape is free to couple with surgical equipment or to a coupler for coupling surgical equipment to a camera.

9. The device according to any one of the preceding claims, further comprising a handle portion and/or a spindle.

10. The device according to claim 9, wherein the handle portion is formed by the container, preferably by the first and/or second sheet.

11. The device according to any one of the preceding claims, wherein the first and/or second sheet is made of a film material and/or one or more thermoformed sheets.

12. The device according to any of the preceding claims, wherein the first and second sheets and/or further container parts are adhesively connected or welded together forming a closed seam, an open seam and/or a plurality of seams.

13. The apparatus of any one of the preceding claims, wherein the first sheet and/or the second sheet are made of a flexible material such that the container is adapted to compress the accommodated annular drape portion between the first sheet and the second sheet.

14. The apparatus of any preceding claim, wherein the cross-sectional geometry of the tubular drape, the received annular drape portion, the first opening, and the second opening is circular, elliptical, or polygonal, or a combination thereof.

15. An apparatus according to any preceding claim, wherein the ratio between the height of the accommodated annular drape portion and the respective length of the extended drape portion in the axial direction is between 1/50 and 1/150, preferably between 1/75 and 1/125.

16. The apparatus of any of the preceding claims, wherein the length of the drape is between 1800mm and 3000mm, and/or wherein the drape is made of a film material having a thickness between 0.02mm and 0.06 mm.

17. The device according to any one of the preceding claims, wherein the first and/or second sheet is substantially free of perforations around its opening, in particular free of radially extending perforations extending radially outward from the opening of the first and/or second sheet.

18. A method for manufacturing an apparatus comprising a tubular drape and a container, the method comprising the steps of:

a) the bottom container part is arranged on a mandrel,

b) a drape is placed over the mandrel,

c) disposing an upper container component over the mandrel and a portion of the drape, wherein a majority of the drape is located between the upper container component and the lower container component, and at least one end portion of the drape is located outside of the container component,

d) compressing the drape in an axial direction between the upper and lower container parts,

e) closing the container, and

f) a separating device and a mandrel.

19. The method of claim 18, the mandrel having a diameter less than a diameter of the drape and less than or similar to an opening in the upper container member and less than or similar to an opening in the lower container member, the opening configured to pass the mandrel therethrough, wherein the step of closing the container comprises the step of welding or adhesively connecting the upper and lower container members while compressing the drape in an axial direction.

20. The method of claim 19, further comprising the steps of:

a) forming one or more engagement flanges of drape material before or after disposing the drape over the mandrel, and

b) not only engage the upper and lower container members, but also engage one or more engagement flanges of the drape, with the one or more engagement flanges located therebetween, or alternatively disposed through an opening in the lower container member and connected to an exterior face of the lower container member.

21. The method of any one of claims 18 to 20, wherein the apparatus is an apparatus according to any one of claims 1 to 17, wherein the upper container part is a first sheet and the lower container part is a second sheet.

Technical Field

The present invention relates to a tubular drape for covering an endoscopic camera and a container for storing and dispensing such a drape.

Background

Modern surgical endoscopes can be connected to a video camera to generate and display images. For this purpose, for example, the international standard ISO/TS 18339: 2015(en) "endoscopic devices-Eyepiece cap and light guide connector" details the design of the endoscope's Eyepiece cap and light guide connector to achieve a combination of products from different manufacturers. The eyepiece cover is the portion of the endoscope at the proximal end of the endoscope to which a video camera or video camera can be attached. As detailed by the standard, the eyepiece has a generally conical shape with a lumen for optical image transmission. Similar explanations are possible in other standards. The present invention is not limited to endoscopic therapy, but can be applied to all fields of endoscopy.

While endoscopes can be sterilized, cameras used with endoscopes are generally not sterile. To maintain the sterility of the surgical procedure, the camera may be covered or enclosed with a sterile drape or the like. One way to cover the camera is to attach a drape (such as a tubular plastic film) to the eyepiece cover and enclose the camera. The coupling may be used to maintain a sterile barrier when the endoscope is replaced. With such a coupling, the endoscope can be replaced while the sterile barrier is maintained during the ongoing surgical procedure.

Regardless of whether a coupler is used, applying drapes in a surgical environment can be challenging given the risk of breaking a sterile barrier or creating a barrier that is initially non-sterile. When covering a camera with an attached cable with a tubular drape, the drape needs to be draped over the camera while maintaining sterility at the desired location.

A tubular drape comprising a sleeve and an annular former is known from US 6,123,080. The proximal region of the drape is mounted on the radially outer periphery of the tubular former in a multi-layer snug fit (snap fit), wherein the drape (cannula) can be withdrawn from the tubular former by pulling it layer by layer. However, this solution has the disadvantage of a complex and expensive multi-part tubular former, and has a complex and expensive assembly process to wind the snug fit onto the former. In use, this solution also has the drawback of a fixed-geometry former, the diameter of which defines irrevocably the device compatibility with the surgical equipment to be covered.

Another tubular drape is known from US 5,078,483. The main drawback of this device is that it needs to be removed in the direction of the endoscope, since the equipment covered by the drape cannot be passed through. Another disadvantage is the complex installation process, involving the subsequent withdrawal of both ends of the tubular drape from the container. Furthermore, the drape is not compatible with the camera coupler device.

Disclosure of Invention

The present invention aims to overcome or at least minimise these problems. In particular, it is an object of the present invention to provide a device for reliably creating a sterile operating room and allowing easy and safe application of tubular drapes to cover surgical equipment. This object is achieved by the device as described in the device independent claim. Embodiments of the invention are recited in the dependent claims. Other embodiments are set forth in the description. Furthermore, the present invention aims to provide a method for manufacturing an apparatus comprising a tubular drape and a container in an economical and reliable manner. This object is achieved by the method described in the independent method claim. Embodiments of the invention are recited in the dependent claims. Other embodiments are set forth in the description.

The present invention relates to an apparatus comprising a tubular drape for covering surgical equipment and a container adapted to contain a substantial portion of the drape in an annular shape in an axially compressed state, the container being open radially inward. The invention also relates to a method for manufacturing a device comprising a tubular drape and a container.

The device may be used to cover surgical equipment, such as cameras and camera cables for endoscopic use. When the camera is attached to the camera port of the endoscope, an image signal transmission cable may extend from the camera to an image display device, such as a computer having a display. Thus, the surgical equipment including the camera and camera cable may have a generally elongated geometry and may bend during use. It is therefore preferred that a tubular drape, particularly an elongate tubular drape, of flexible material may be suitable for covering such surgical equipment. To create a sterile barrier, a drape may be connected or attached to the endoscope or an intermediate component (such as a coupler), and the drape may include a sterile barrier side (facing the operating room) and a non-sterile barrier side (facing the camera and/or cable).

When applying or mounting the tubular drape to the surgical equipment to be covered, the tubular drape may be pulled or pulled over the equipment starting from one end in a relative movement until the surgical equipment is covered in an appropriate manner.

The device according to the invention comprises a container adapted to contain a substantial part of the drape in an axially compressed state. The majority of the drape refers to a portion of the drape that extends along the tubular axis of the drape from a starting point to a terminal point. Typically, this constitutes more than 50%, more typically more than 70%, preferably more than 90% of the drape in the axial direction. The majority may or may not include one or both ends of the tubular drape. Preferably, the receptacle is adapted to receive a majority of the drape (including one drape end). When received, the portion of the drape is positioned within the container geometry.

In the axially compressed state, the tubular drape is compressed in the direction of the tubular axis. In other words, when the drape portion is in the compressed state, the drape portion does not fully extend in the axial direction, as compared to the extended state. Such compression may be achieved by folding, filling (stuff), stuffing (cram), crumpling, and the like. This compression may be achieved by concertina (concertina) folding. A portion of the drape in an annular shape in an axially compressed state may have a geometry generally similar to a geometric circular ring (geometric torus), having an outer perimeter and an inner perimeter, leaving an opening inside the inner perimeter. The annular shape may have a generally circular shape (e.g., a circular ring), or an elliptical shape, or a polygonal shape, or a combination thereof. The annular shape may be achieved by a plurality of folded layers of the tubular drape, generally transverse or orthogonal to the tubular axis, wherein the layers are stacked on each other in the axial direction. Alternatively or in combination therewith, the annular shape may be achieved by a plurality of folded layers generally parallel to the peripheral wall of the drape tube, wherein the layers are stacked on each other in the radial direction. The loop shape may also be achieved by packing the drape into a loop geometry. Thus, a large number of asymmetric layers or corrugations may form an annular shape. The container may apply a force in an axial direction corresponding to a compression force of the drape. The container may direct this force in an axial direction from one side to the opposite container side. Axial compression may help retain the drape within the container. Compressive forces in the axial direction may result in frictional forces in the radial direction.

The container may be open inwardly. The inwardly open container is at least partially open to the container interior. There may be a free space between the portion of the interior of the container near its outer periphery and the inner core of the container. The free space may preferably communicate with the outside of the container via the first container opening. For example, if the container has a generally cylindrical outer shape, there is a space between the interior of the outer cylindrical wall and the axis of the cylinder, and this space may allow communication therebetween. However, if such a container, having a generally cylindrical outer shape, additionally has an inner geometry with a cylindrical wall extending completely along the axis of the outer cylinder, the inner cylindrical wall blocks the communication between the interior of the outer cylindrical wall and the axis of the cylinder. As another example, a container having a closed-loop shape does not open inwardly because the inner annular wall blocks communication between the interior of the outer annular wall and the axis of the annular ring, and because it does not allow communication with the exterior of the container. A container having a generally cylindrical outer shape may have a mandrel (mandrel) extending along only a portion of the axis of the cylinder, leaving space for the container not to extend along the axis of the cylinder to open inwardly. However, the container may not be inwardly open if the mandrel extends along the axis up to two cylindrical ends or more than two cylindrical ends.

The drape may be made of a film material and/or a fabric material. The film material may be a plastic film material such as, for example, polyethylene or polyvinyl chloride. It may be a textile material or a film and a textile, such as a composite coated textile material. These materials may be beneficial to make the drape a sterile barrier and allow movement of the covered surgical equipment. The membrane material and/or the fabric material may be adapted for annular compression of the drape in the axial direction.

The container may comprise a first sheet and a second sheet, wherein the first sheet and the second sheet are oppositely arranged, the first sheet having a first opening and the second sheet having a second opening. The sheet may extend further in two dimensions (width and length) than in the third dimension (height). The sheet may be flexible so that it may assume different shapes. The sheet material may also be a hard (solid) and/or rigid (stiff) material. It may be flat in a planar sense, or it may be bent, flexed, molded or otherwise shaped in three dimensions. The first and second sheets may be made of a film material and/or one or more thermoformed sheets. Such film material may be foil, paper, cardboard or other material. The first and second sheets may be separate components, they may be part of other components, or they may be integrally formed, even if the two sheets are formed in one integral component. The first sheet and the second sheet may be made of one sheet. The sheet material may form the ends of the container in both axial directions. The sheet may define the contained drape portion in an axial direction. The container may include one sheet of thermoformed sheet material and a second sheet of film material, the thermoformed sheet being deep drawn or otherwise thermoformed in an axial direction relative to the tubular axis of the drape being received. The opening may be a missing portion of the sheet (osis), such as a hole. Such openings may be circular, oval, polygonal, or a combination thereof.

The first sheet and/or the second sheet may be made of a flexible material such that the container is adapted to compress the received loop portions between the first sheet and the second sheet. The flexible sheet may act flexibly on the accommodated drape portion and adapt (adapt) to its shape. The shape may vary depending on the degree and technique of compression. Also, the compression may vary depending on the material and shape of the container.

The first opening may be configured for withdrawing the drape from the container. When a portion of the drape is received within the container, the portion of the drape, or a sub-portion thereof, may be extracted from the container by moving the portion or the sub-portion thereof through the first opening. The diameter of the first opening may be smaller than the diameter of the tubular drape in the radially extended state. In this case, the drape may be locally and temporarily compressed or tapered radially to pass through the first opening. In this case, the first opening may resemble a bottle neck through which a drape will pass. If a sub-portion of the drape is withdrawn through the first opening, the remaining portion may remain inside the container. The extraction can be performed in a discontinuous layer-by-layer manner or in a continuous manner. The extraction may be achieved by pulling the drape portion not housed inside the container away from the container in a direction similar or identical to the direction of the tubular axis. The extraction may be limited by attaching the drape to the container, or unrestricted to allow full extraction of the drape. The same applies to the second opening, in which case the drape is withdrawn in the opposite direction compared to the first opening. Friction may be applied between the container and the drape. In particular, a friction force may be applied between the accommodated portion to be extracted and the first sheet. The contained drape portion may be in a compressed state, wherein the compressive force corresponds to a force between the container and the drape in the axial direction. The compressive force in the axial direction may mechanically influence the extracted friction force. The compression force may be reduced as the drape is withdrawn and as fewer drape sub-portions remain contained within the container. Accordingly, the frictional force can be reduced.

The first and second openings may be configured for passing surgical equipment to be covered therethrough. When applying a tubular drape over an elongated surgical instrument in the direction of the tubular axis, this may involve or require withdrawing the contained portion of the drape from the container. This may be achieved by placing the container at a position relative to (e.g., at one end of) the apparatus, and then first withdrawing the drape through one end of the drape in the direction of the apparatus. Alternatively, the drape end may be fixed relative to or attached to the fixture, with the container being pulled through the elongated fixture, thereby continuously withdrawing the drape portion while pulling the container away from the drape end. For this purpose, the first and second openings may be configured to pass surgical equipment to be covered therethrough. The first opening and the second opening may be circular. They may have a diameter larger than the diameter of the device to be covered. They may be configured to pass both drapes and surgical equipment therethrough. In particular, in the case of a bottleneck configuration, the drape may be located between the opening and the surgical equipment in the radial direction. The opening may be variable or flexible, adapting to the cross-sectional geometry of the surgical instrument passing therethrough.

The received ring portion may define an axis, and the opening of the received ring portion may be configured for passage of surgical equipment therethrough. The opening of the received annular portion may be substantially circular or elliptical. The opening shape may be affected by multiple layers or folds of the contained drape in the compressed state. The diameter of the opening in at least one direction may be greater than the diameter of the device to be covered and passed therethrough.

The opening of the received annular drape portion, the first opening, and the second opening may be substantially aligned with respect to the axis. Their axes may be coaxial, which means parallel and positioned the same, or substantially parallel and substantially close to each other with a point of intersection at the device. The aligned axes may be beneficial and facilitate the passage of surgical equipment therethrough. Aligning the opening of the annular drape portion with the first opening may be beneficial for withdrawal of the drape therefrom. The first opening may be a neck for the drape and, when aligned therewith, the drape may pass well therethrough.

The first sheet material may include a dispensing lip at an edge region of the first opening. The dispensing lip may be open or closed, or may comprise multiple lips. It may be circular or elliptical or polygonal. The lip may be flexible and may change when force is applied, however the dispensing lip preferably does not tear, for example along any perforations or the like. It can be closed and resist pulling forces. The dispensing lip may be subject to forces applied in a radial and/or axial direction when in the bottleneck configuration and the drape passing therethrough. In combination with the first and second sheets, the dispensing lip can both maintain a compressive force in the axial direction while allowing the drape to be retracted. The dispensing lip may be adapted to provide friction when in contact with another material (e.g., a drape). The dispensing lip may be made of a resilient or non-resilient material. The first sheet material may comprise an attachment portion positioned radially outward of or distal from the dispensing lip, wherein the attachment portion may connect the first sheet material with the second sheet material. The second sheet may have a corresponding attachment portion. The container may comprise a cylindrical member, which is generally cylindrical and connects the first and second sheets. Alternatively, the attachment portion may directly connect the first and second sheets, which may together form the body of the container. The attachment portion may circumferentially surround the dispensing lip.

The first end of the drape may be attached to the container and/or the first end of the drape may be located inside the container, and the other end of the drape may be free to couple with surgical equipment or to a coupler for coupling the surgical equipment to a camera. The first end may be part of a portion of a drape received in the container. The other end may be free to couple with the surgical instrument, which means that it is not housed inside the container and therefore not extracted. Extraction of the drape from the container may be accomplished by pulling the other end away from the container until a portion of the drape or the entire drape is extracted. The attachment between the two may prevent separation when the drape is (almost) completely withdrawn from the container. Such separation may be undesirable during surgery, as such events may interfere with the process of reliably constructing a sterile barrier between the camera and the surgical environment. When the first end of the drape is located inside the container and attached to the container, it may be attached to a point inside the container and/or between the first sheet and the second sheet. The drape may pass from inside the container through a second opening (e.g., a second bottle neck) for attachment to the outside of the container. In the latter case, the first end is attached to the container but not inside the container. The first end of the drape may not be tubular, unlike other geometries thereof. The first end of the drape may include one or more engagement flanges that are attachable to the container. The engagement flange may be formed from the tubular drape by cutting or otherwise forming one or more slots in the first end of the tubular drape. The other end of the drape may be attached to a camera coupler or other surgical equipment.

The device may include a handle portion. The handle portion may be a portion of the container configured for manual grasping. It may also be a separate component connected to the container. The handle portion may be formed by the container, preferably by the first sheet and/or the second sheet. The first and second sheets may be radially attached outside of the received annular drape. The first and second sheets may be attached in a parallel or coplanar manner. The first and second sheets may extend radially beyond their attachment portions to form one or more handle portions radially outward of the received annular drape. The handle portion may be two oppositely arranged handle portions, adapted to be gripped one by each hand.

The handle portion may include a non-sterile portion. The non-sterile portion may be a portion that is grasped by non-sterile surgical personnel. During surgery, creating a sterile barrier may require distinguishing between sterile and non-sterile zones. In the example of an elongated surgical instrument covered by a tubular drape, relative movement between the instrument and the drape may be required. For example, if the surgical equipment to be covered is not sterile but needs to be grasped and held, these non-sterile hands must not touch the sterile portion of the drape, particularly the exterior of the tubular cover. By clearly indicating which hand can be grasped in which position, the non-sterile area on the device can clearly and safely help create a sterile barrier. The non-sterile zone may, for example, be indicated by a different color than the sterile zone.

The apparatus may also include a mandrel. The mandrel may have a cylindrical shape and may be located radially inward of the received annular drape portion. The mandrel may bound the annular drape in a radially inward direction, defining an opening at the location. It may be made of a flexible or rigid material. The mandrel may leave an opening between the mandrel and the first opening for the drape to pass through when withdrawn. To open the container inwardly, the mandrel may not extend axially up to or beyond both ends of the container or up to or beyond both the first and second sheets without leaving an opening. The present invention does not necessarily and generally require a mandrel. However, it may be useful in the context described above.

The container may have an annular dispensing opening. An annular dispensing opening may be formed between the exterior of the inner core of the container and the inner periphery of the dispensing lip of the outer container part. The inner core of the container may be radially inward relative to the outer container part. The inner core may have an annular shape. The inner core may be a container mandrel. The axis of the inner core and the axis of the outer container part may be aligned. The outer container component may be formed from the first sheet and/or the second sheet. The dispensing opening may be annular when the inner core is internally restricted and the outer container part is externally restricted relative to the axis of the ring. The annular opening may be an annular gap between the outer container portion and the inner container core. The exterior of the core may be the outer circumference of the core of the container.

The annular dispensing opening may correspond to the first opening in the first sheet. The dispensing lip of the outer container member may correspond to the dispensing lip at the edge region of the first opening. The inner core may be integrally formed with the second sheet. The inner core may extend in the direction of the container axis within the limits (limit) of the first and second sheets, the inner core may also extend in the axial direction beyond the first sheet and/or beyond the second sheet.

The first and second sheets and/or further container parts may be adhesively connected or welded together. This may be done by, for example, thermal or ultrasonic welding. The adhesive attachment may be by the application of glue or other adhesive means (e.g., an adhesive film). Such a connection may be established by means of a closed seam, preferably a seam circumferentially around the accommodated annular drape. A seam (preferably closed) around a contained drape may have the advantage of limiting lateral movement of the drape and defining a loop and/or compression thereof. Alternatively, the seam may be open or divided into multiple seams. The sheet material may form a handle portion, which may include additional seams. Other container parts may also be connected. A drape (preferably a drape end) may also be attached. One or more joining flanges of the drape may be connected (e.g., welded) between the first sheet and the second sheet.

The accommodated annular drape portion may have a mechanical stiffness that mainly contributes to the overall stiffness of the device. Depending on the degree of compression and the construction of its layers, the received annular drape portion itself or together with the container around it provides significant rigidity. Thus, although the container is otherwise flexible (e.g. because it comprises a flexible sheet), the stiffness of the annular received drape portion may contribute primarily to the overall stiffness of the apparatus. In particular, the annular received drape portion may be the most rigid component of the overall device. For example, the rigidity of an annular drape portion like this is at least such that it is not substantially deformed or deformed at all when held at an arbitrary portion of the ring, i.e., the side opposite to the position of holding is not deformed downward by the action of gravity and preferably is not deformed when an additional mass of 50g, more preferably 100g, is applied to the opposite portion. This feature may reduce the mechanical requirements of the container and thus the complexity and cost of the container, and allow the use of, for example, flexible materials as container components.

The shape of the tubular drape is not limited to a tube in the sense of a cylinder having a circular cross-section. Further, the tubular drape may have an elliptical, polygonal cross-section, or a combination thereof. The drape may also be a "flat" tubular drape. The width of such a flat tubular drape is typically between 120mm and 170 mm. Thus, the received annular drape portion, first opening, and second opening are not limited to strictly circular cross-sections. The combination of geometries between the components may have additional advantages with respect to extraction mechanisms, compression and accommodation, and multiple functions of the device.

The ratio between the height of the accommodated annular drape portion and the respective length of the extended drape portion in the axial direction may be between 1/50 and 1/150, preferably between 1/75 and 1/125. The length of the drape may be between 1800mm to 3000 mm. The drape may be made of a film material having a thickness between 0.02mm and 0.06 mm. The first opening, the second opening and/or the opening of the received annular drape portion may have at least one diameter greater than 50mm, preferably greater than 70 mm.

Furthermore, the invention relates to a method for manufacturing a device comprising a tubular drape and a container, the method comprising the steps of: the method includes the steps of placing or threading a bottom container component on a mandrel, placing or threading a drape on the mandrel, placing or threading an upper container component on the mandrel and on a portion of the drape, wherein a majority of the drape is located between the upper and lower container components, and at least one end portion of the drape is external to the container component. Other steps are compressing the drape axially between the upper and lower container members; closing the container; and separating the device from the mandrel. The steps may be performed in the order given above. However, the order may also be changed.

The tubular drape may be made of a flexible material, preferably a film material. The upper and bottom container members may each be made of a sheet material that is either rigid or flexible (e.g., a film-like material). Both container parts may have openings to allow them to be arranged or threaded on a mandrel.

The mandrel may be a cylindrical manufacturing tool. It may be attached to a table or the like. Its height may vary, as well as during device fabrication.

Arranging or threading the bottom container part on the mandrel may involve passing the opening of the bottom container part through the end of the mandrel and then sliding it over at least a portion of the mandrel, preferably up to an end position or end stop on a table, for example.

The length of the tubular drape may be greater than the length of the mandrel. Threading the drape over the mandrel may involve threading an end of the drape over the mandrel, sliding the end along the mandrel. The end that is first threaded on the mandrel may be referred to as the bottom end. It may involve threading some or all of the drape over a mandrel. It may involve compressing the drape in its axial direction and/or the direction of the mandrel axis. Compressing the drape may be accomplished by folding or tucking the drape. The packing may be accomplished by axially moving the tool and/or hand, thereby sliding the top end in the direction of the bottom end of the drape.

Arranging or threading the upper container component over the mandrel and over a portion of the drape may be accomplished by threading an opening of the upper container component over the mandrel and over a portion of the drape. The drape portion may include an upper end of the drape, which is the opposite end of the drape as the lower end, which is threaded over the mandrel first. The drape portion may surround the mandrel at a given point. The majority may be located between the upper and lower container parts. The portion of the drape is compressible in an axial direction between the upper and lower container components.

The container may then be closed. This step may include welding or adhesively connecting the upper and lower container members while compressing the drape in the axial direction. This may involve ultrasonic welding. Ultrasonic welding tools may also be used for drape compression.

The device and the mandrel may be separated by removing the device from the mandrel. Alternatively or in combination, the mandrel may be removed, for example, mechanically and/or automatically.

The drape may be attached to the container. The method may comprise the steps of: one or more engagement flanges of drape material are formed before or after the mandrel is placed or threaded on the mandrel. Such an engagement flange may be formed by cutting one or more slots in the tubular drape. The one or more engagement flanges may be attached to the lower container part and/or the upper container part. They may be attached inside and/or between the two. They may be penetrated by the lower container part and connected to the outside of the lower container part.

Drawings

The invention will be further explained by referring to the drawings. Note that the drawings are used to explain certain features that are optional to the invention. The figures are not to be construed in a limiting manner and any feature discussed with reference to a figure may be present in other embodiments alone or in combination with one or more other features.

Fig. 1 shows a schematic perspective view of a device according to an embodiment of the invention;

fig. 2 shows a schematic cross-sectional view of an embodiment of the device according to the invention;

FIG. 3 shows the device of FIG. 2 in a top view;

4A-4C illustrate different geometries of a contained drape portion and a polygonal seam according to embodiments of the invention;

FIG. 5A shows a schematic half-sectional view of an embodiment of a device according to the invention;

FIG. 5B shows a schematic half sectional view of another embodiment of a device according to the invention;

FIG. 5C shows a schematic half-sectional view of another embodiment of a device according to the present invention;

FIG. 5D shows a schematic half-sectional view of another embodiment of a device according to the present invention;

FIG. 5E shows a schematic half-sectional view of another embodiment of a device according to the invention;

FIG. 6 shows an apparatus according to an embodiment of the invention in the context of an endoscope, a camera coupler, a camera, and a camera cable;

FIGS. 7A-7C illustrate steps of a method of manufacture according to the present invention;

figure 8A shows an apparatus for measuring the radial stiffness of an annular drape portion;

fig. 8B, 8C show an apparatus for measuring the bending stiffness of an annular drape portion.

Description of reference numerals:

2 device

4 tubular drape

6 container

8 contained drape portion

10 annular shape

12 handle part

14 first sheet

16 second sheet material

18 first opening

20 second opening

22 axis

24 dispensing lip

26 edge region of the first opening

30 attachment portion of first sheet

28 first end of drape

Second end of 32-drape

34 Container mandrel

36 welding seam

38 joint flange

40 layers of

42 outer drape portion

44 drape neck

46 first side portion

48 second side part

50 first sheet exterior face

52 first sheet inner face

54 bottleneck clearance

56 attachment portion of second sheet

58 camera coupler

60 handle part weld

62 outer sheet edge

64 non-sterile zone

66 polygonal seam

68 Camera

70 Camera Cable

72 endoscope

100 manufacturing mandrel

102 bottom container part

104 upper container part

106 inner core

108 outer container component

110 annular dispensing opening

M1 direction

Direction D1

Direction D2

F_EForce of

F_RForce of

L_EDistance between two adjacent plates

L_RDistance between two adjacent plates

Detailed Description

Fig. 1 shows a device 2 according to an embodiment of the invention in a perspective view. The tubular drape 4 may extend beyond the range shown in the figures. The second end 32 of the tubular drape 4 may be attached to a camera coupler (not shown). The drape portion 8 of the drape 4 may be housed in the container 6. The outer drape portion 42 may be located outside the container 6. The contained drape portion 8 may be in an axially compressed state in a ring shape. The container may be open radially inward. The container may include a first sheet 14 and a second sheet 16. The first sheet 14 may include a first opening 18. The first sheet 14 may include a dispensing lip 24 at an edge region 26 of the first opening 18. The first sheet 14 and the second sheet 16 may be joined by a weld 36. The device 2 may comprise a handle portion 12 which may be formed by the container 6 and may comprise two handles located on opposite sides of the container 6. The drape 4 may pass through the first opening 18 forming a drape neck 44. The diameter of the drape neck 44 may be less than the diameter of the tubular drape 4 in the radially expanded state. The first sheet 14 may surround the received annular drape portion 8.

Fig. 2 shows a cross-sectional view of a slightly modified embodiment of the device 2 according to the invention. The container 6 may include a first sheet 14 and a second sheet 16. The first sheet 14 may include a first opening 18. The second sheet 16 may include a second opening 20. The first sheet 14 may include a dispensing lip 24 at an edge region 26 of the first opening 18. In this embodiment, the first sheet 14 may have a first side portion 46 and the second sheet 16 may have a second side portion 48. The first side portion 46 and/or the second side portion 48 may have a cylindrical or conical shape. In other respects, this embodiment largely corresponds to the embodiment shown in fig. 1.

The first sheet 14 may include an attachment portion 30. The second sheet 16 may include an attachment portion 56. The first sheet 14 and the second sheet 16 may be attached to each other. A weld 36 may connect the two sheets. The drape 4 may be attached to the container 6. To this end, one or more engagement flanges 38 or another component of the drape 4 may connect the first and/or second sheets 14, 16. Preferably, two or more joining flanges 38 of the tubular drape 4 are welded to the first and second sheets 14, 16 by welds 36 at the attachment portions 30, 56. The engagement flange may correspond to a first end of the drape 28. The device may include a handle portion 12. The container 6 may form a handle portion 12. The handle portion 12 may comprise two handles located at opposite sides of the container. One or more handle portion welds 60 may connect the first sheet and the second sheet. The one or more welds 60 may be located at an outer edge 62 of the vessel. The apparatus 2 may include one or more non-sterile zones 64. The handle portion 12 may be a non-sterile field 64. The term "non-sterile field" does not necessarily mean that the field is not sterile, but rather that the field may be used in conjunction with a non-sterile environment, e.g., it may be in contact with a non-sterile camera or the like or with non-sterile surgical personnel. Preferably, the entire device is sterile prior to use.

The majority 8 of the drape 4 may be contained in a ring shape inside the container 6 in an axially compressed state. The received portion 8 may include multiple layers 40 of the drape 4. These layers 40 may be symmetrical or asymmetrical and/or corrugated. Alternatively or additionally, the received portion 8 may be padded (crammed). The multiple layers 40 of the drape 4 may be arranged or stacked in the axial direction and/or in the radial direction. Compression of the accommodated drape portion 8 may result in a compressive force in the axial direction. Such a force may correspond to a force applied to the container 6 in an axial direction. The shape of the contained drape portion 8 may correspond to the shape of the container 6. The first sheet 14 and/or the second sheet 16 may be made of a flexible material.

The drape 4 may pass through the first opening 18 with the drape neck 44 portion between the outer drape portion 42 and the received drape portion 8. At the drape neck 44, the drape 4 may have a neck gap 54. The drape neck 44 may be an opening having a diameter of the neck gap 54 that allows surgical equipment to pass therethrough. The first sheet 14 may include a first sheet outer face 50 and a first sheet inner face 52. In the compressed state in the axial direction, the accommodated drape portion may be in contact with the inner face 52. Forces, such as friction, may occur between the inner face 52 and the drape. Such friction may prevent the drape from moving through the first opening 18. When the second end 32 of the drape 4 is pulled away from the container 6 along direction D1, the contained subpart of the drape 4 may be withdrawn from the container 6.

The tubular drape 4 may have an axis 22. The axis of the first opening 18, the axis of the second opening 20, the axis of the weld 36, and the axis of the first side portion 46 and/or the axis of the second side portion 48 may be aligned. They may also be considered aligned, for example, if they intersect and are substantially parallel at the device.

The container 6 may be open radially inward. The cross-sectional shape of the container may be described as two opposing, mirror-symmetrical "C" shapes. There is no mandrel, core or axial wall that inwardly closes the container.

Fig. 3 shows the apparatus of fig. 2 in a top view, including the container 6 and the tubular drape 4. From a top view, the first sheet 14 is visible, wherein the underlying second sheet 16 is not visible in fig. 3. The welds 36 and 60 may not be visible because they may be below the first sheet 14 from a top view. Welds 36 and 60 may be located as shown in phantom. The weld 36 may join the first sheet 14 with the second sheet 16. The weld 36 may define the annular shape 10 of the received drape portion 8 in a radially outward direction. The second end 32 of the drape 4 may be external to the container and may be a component of the outer drape portion 42. A drape neck 44 may be located between the accommodated drape portion 8 and the outer drape portion 42. The bottleneck gap 54 may define an annular, received drape portion 8 opening and/or a device opening at the first opening 18. The first sheet material may include a dispensing lip 24 at an edge region of the first opening 18. The first sheet 14 and/or the second sheet 16 may include an outer sheet edge 62. The device 2 may include a handle portion 12, which may include two handles arranged in a symmetrical relationship. The apparatus may include a non-sterile zone 64. The non-sterile field 64 may be the handle portion 12. The first sheet 14 and the second sheet 16 may form the handle portion 12. A handle portion weld 60 may connect the two sheets at the handle portion 12. The handle portion 12 may include one or more missing portions of material, such as holes, forming a handle.

Figures 4A-4C illustrate different geometries of a contained drape portion and a polygonal seam according to embodiments of the invention. A polygonal seam 66 may connect first sheet 14 (not shown) with second sheet 16 (not shown). The seam 66 may have a polygonal shape. The contained drape portion 8 may have a donut shape 10.

Fig. 5A shows a half-sectional view of an embodiment of the device according to the invention. The container 6 may be integrally formed as one piece comprising a first sheet 14 and a second sheet 16. In other words, the first sheet 14 and the second sheet 16 are unitary and form an envelope-like configuration prior to closing the container. The drape portion 8 may be housed therein while the other drape portion 42 is external with respect to the container.

Fig. 5B shows a half-sectional view of another embodiment of a device according to the invention. The container 6 may include a first sheet 14, a second sheet 16, a weld 36 therebetween, and a container mandrel 34. The drape portion 8 may be housed in the container 6. The container mandrel 34 may extend in an axial direction from the second sheet 16. The container mandrel 34 may define the annular shape 10 inwardly. From its annular accommodation within the container 6, the drape 4 may pass inwardly and axially out of the container to the outer drape portion 42. The container mandrel 34 may extend beyond the first sheet 14. The second sheet 16 and the container mandrel 34 may be made of the same material and may be formed from one integral component. The integral component may be a thermoformed sheet. The integral part may have an L-shape in a half sectional view. The container mandrel 34 may correspond to the inner core 106 of the container. The outer container component 108 may be formed from the first sheet 14. An annular dispensing opening 110 may be formed between the exterior of the inner core 106 of the container and the inner periphery of the dispensing lip 24 of the outer container component 108.

Fig. 5C shows a half-sectional view of another embodiment of a device according to the invention. In this embodiment, the second sheet 16 is a hard (solid) or rigid (rigid) sheet, or at least it is less flexible than the first sheet 14, i.e., the first sheet 14 may be more flexible. For example, the first sheet 14 may be made of a film material, while the second sheet 16 may be made of a thermoformed sheet. Although fig. 5C shows the first sheet 14 extending in the axial direction more than the second sheet 16, vice versa, or both may be formed with a substantially symmetrical extension. The first sheet 14, the second sheet 16, and/or the joining flange 38 of the drape 4 may be connected by a weld 36.

Fig. 5D shows a half-sectional view of another embodiment of a device according to the invention. In some respects, it is similar to fig. 5C. However, in this example, the first sheet 14 is a hard or rigid sheet or a less flexible sheet, wherein the second sheet 16 may be more flexible. For example, the second sheet 16 may be made of a film material, while the first sheet 14 may be made of a thermoformed sheet. While fig. 5C shows the first sheet 14 extending in the axial direction more than the second sheet 16, vice versa, or both may be formed with a substantially symmetrical extension.

Fig. 5E shows a half-sectional view of another embodiment of a device according to the invention. The container 6 may include a first sheet 14, a second sheet 16, and a container mandrel 34. The drape portion 8 may be housed in the container 6. The container mandrel 34 may extend in an axial direction from the second sheet 16. The container mandrel 34 may define the annular shape 10 inwardly. The container 6 may be open inwardly. From its annular accommodation within the container 6, the drape 4 may pass inwardly and axially out of the container to the outer drape portion 42. The container mandrel 34 does not extend to or beyond the first sheet 14 and the second sheet 16, thus leaving a space to open it inwardly.

Fig. 6 shows the apparatus according to an embodiment of the invention in the context of an endoscope 72 (partially shown), a camera coupler 58, a camera 68, and a camera cable 70 (partially shown). The camera coupler 58 may be attached to the second end 32 of the drape 4. The camera coupler 58 may be removably connected to the endoscope 72 on the outside and removably connected to the camera 68 on the inside. Fig. 6 shows the device in the following state: a portion of the camera 68 and camera cable 70 is covered by the outer portion 42 of the drape 4. The container may contain a further portion 8 of the drape 4 (not shown) housed in the container 6. By pulling the container 6 away from the endoscope 72 in direction D2, with the second end 32 of the drape connected to the endoscope 72 via the coupling 58, additional sub-portions of the contained drape are withdrawn from the container 6. The sides of the container 6 and the inside of the drape portion 42 facing the camera 68 and the cable 70 may be or become the non-sterile zone 64. The exterior of the coupling 58 and the exterior of the outer portion 42 of the tubular drape 4 may be sterile zones. The camera 68 and camera cable 70 may be non-sterile. Thus, the drape forms a barrier between the sterile and non-sterile components.

Fig. 7A-7C illustrate steps of a method according to the invention for manufacturing a device such as described above with reference to fig. 1-5. Figure 7A shows the fabrication mandrel 100 and the tubular drape 4. The drape 4 may be placed or threaded onto the manufacturing mandrel 100 in the direction M1. The drape may be compressed in that direction.

Fig. 7B shows the manufacturing mandrel 100, the tubular drape 4, the bottom container member 102, and the upper container member 104. The drape 4 may be compressed in the axial direction between the bottom container member 102 and the upper container member 104. A portion of the drape that is compressed in the axial direction may be located between the upper and lower container members 104, 102.

Fig. 7C shows the apparatus being manufactured, which includes the drape 4, the camera coupler 58, the upper container member 104, and the lower container member 102. The device may be withdrawn from or separated from the manufacturing mandrel. The container parts 102 and 104 may be connected. They may form a container. The camera coupler 58 may be attached to the drape 4.

Fig. 8A shows a device (set-up) for measuring the radial stiffness of the annular drape portion 8. Fig. 8B and 8C illustrate an apparatus for measuring the bending stiffness of the annular drape portion 8. These devices are not necessarily specific to the above-described embodiments of the present invention.

The tested annular drape portion 8 was made of PE film (density 0.92 g/cm)³) Is made of a tubular drape section of 2.5m in length and approximately 0.04mm in thickness (approximately 205mm in planar width). The diameter of the tubular drape (before it is converted into a ring) is about 130 mm. The tubular drape is converted as described above for fig. 7A-7C by sliding the tubular drape over the fabrication mandrel and packing it down to a ring having a height of about 25 mm. The ring has an outer diameter of about 140mm and an inner diameter of about 90 mm. The annular drape portion 8 is held in this configuration by the use of four cable ties (cable ties) every 90 degrees and four adhesive strips (adhesive strips) every 90 degrees. The cable ties and adhesive strips are offset 45 degrees from each other so that there is one cable tie in the middle between the two adhesive strips.

The radial stiffness and bending stiffness of the annular drape portion 8 thus prepared, i.e. the "bare" annular drape portion considered without the surrounding container 6, were quantitatively tested as follows.

By applying a linear force F in an outward radial direction between two opposite sides of the "bare" annular portion 8_RThe radial stiffness was measured as shown in fig. 8A. The following results were observed:

thus, when a force F of 4N is applied_RAt the same time, the extension distance or deformation distance L of the annular drape portion_RHolding at most about 2.5mm, more preferably at most about 1.5mm, and even more preferably at most about 1 mm. When a force F of 10N is applied_RAt the same time, the extension distance or deformation distance L of the annular drape portion_RHolding at most about 9mm, more preferably at most about 7mm, and even more preferably at most about 5 mm.

The bending stiffness can be measured as shown in fig. 8B and 8C. Linear force F_BTwo opposing points applied to the annular drape portion in a direction perpendicular to the plane of the annular shape 10. These points are located on a straight line passing through the centre of the annular shape, wherein the reaction force is exerted by arranging the ring on two circular support bars spaced from each other by about 105 mm. Thus, force F_BThe opposite point is bent downwards while the outer point remains stationary. The following results were observed:

thus, when a downward force F of 3N is applied to the opposite point_BThe point is moved by a distance L of about 2.5mm or less_BMore preferably about 1.5mm or less, even more preferably 1.2mm or less. When a downward force F of 6N is applied to the opposite point_BThe point is moved by a distance L of about 8mm or less_BMore preferably about 6mm or less, even more preferably 4mm or less.

Preferably, these aforementioned values apply to any two opposite points of the annular portion, even if said annular portion is not circular or of exactly circular geometry.

The radial stiffness and/or bending stiffness of the annular drape portion that is not accommodated or of the container in which only an annular, very short drape portion is accommodated is significantly lower than the radial stiffness and/or bending stiffness of the annular drape portion quantified above.