Patent Application
20250009384
The present disclosure generally relates to a trocar fixation assembly comprising a fixation device and a medical dressing. The present disclosure also relates to a trocar system comprising the trocar fixation assembly.
Minimal invasive surgery (MIS) is a technique for performing surgery that is associated with less pain, shorter recovery and fewer complications compared to traditional open surgery.
In an MIS procedure, a small incision is typically made through the skin of a patient, and a trocar is thereafter inserted into the incision. The trocar serves as a working channel that allows for the entry of various surgical instruments and cameras into a body cavity, e.g. an abdominal cavity.
A trocar may comprise a cannula and an obturator. The cannula is a hollow and tube-shaped plastic or metallic shaft that is placed inside the patient to provide access to the body cavity during the MIS procedure. The obturator is a sharp tool that allows the cannula to penetrate the body cavity for initial placement. When the cannula has entered the body cavity, the obturator is removed.
To date, the commonly used trocars in MIS procedures include balloon trocars, and Hasson trocars, respectively. A Hasson trocar is a non-bladed trocar that stays in place by means of sutures anchored to the abdominal wall fascia. A balloon trocar comprises a balloon at the end of the trocar that is inflated with air. Instead of utilizing sutures for fixing the trocar, the inflated balloon anchors the trocar in the abdomen.
Fixating and stabilizing the trocar, particularly the cannula, is typically challenging during most MIS procedures. Both the balloon and Hasson trocar system suffer from disadvantages with respect to fixation and stabilization. For example, the inflated balloon of a balloon trocar may rupture, which is associated with risks for the patient. Furthermore, a balloon trocar cannot simply be removed from the body cavity since the balloon must first be deflated.
The Hasson trocar is cumbersome in the sense that fixation and stabilization require the aid of sutures to fixate the trocar in the body cavity. Upon removal of the trocar, the sutures must first be removed. Furthermore, the cannula must typically comprise ridges to fix the skin mechanically.
Trocar cannulas may either have a smooth, threaded, or ribbed outer surface. Threaded and ribbed cannulas provide for some degree of retention, which may prevent the cannula from moving in and out of the body cavity. However, cannulas with a smooth outer surface are easily dislocated and may project out of the body cavity or deeper into the body cavity during use. Such dislocation is risky during surgery, and should be avoided.
Another challenge during MIS procedures is sterility and keeping the surgical site and the area circumventing the trocar clean and free from blood.
Accordingly, there is room for improvements in fixating and stabilizing the trocar in a sterile, simplified and less cumbersome manner. Such fixation and stabilization means should prevent dislocation of the trocar cannula during use and facilitate initial attachment, and removal of the trocar from the body cavity.
In view of the above-mentioned problems, it is an object of the present disclosure to provide improvements with respect to relieving the burden for surgical staff and the patients and providing a facilitated and improved means to handle and fixate a trocar during minimal invasive surgery.
According to a first aspect, there is provided a trocar fixation assembly comprising a fixation device and a medical dressing, wherein the fixation device comprises an annular member defining a channel for receiving a trocar; the annular member being disposed about a longitudinal center line, wherein the fixation device is movable between a first configuration, which allows for a trocar to be moved along the longitudinal center line of the annular member, and a second configuration, which allows for a trocar to be fixed in a locked position, wherein in the second configuration, the cross-sectional area of at least one portion of the channel is smaller than the cross-sectional area of the at least one portion of the channel in the first configuration.
The present disclosure is based on the realization that a trocar fixation assembly according to the present disclosure greatly facilitates the minimally invasive surgical procedure for the surgeon and for the surgical staff. The trocar fixation assembly provides for a safe surgical procedure, avoiding undesired intervention in the patient during fixation and stabilization of the trocar.
The trocar fixation assembly is configured to be shifted between a first and a second configuration. In the first configuration, the cross-sectional area of at least a portion of the channel is larger, and a trocar; i.e. trocar cannula may be moved along the longitudinal center line; i.e. into and out of the body cavity. Accordingly, in this configuration, the surgeon or surgical staff may insert the trocar into the body cavity and adjust the depth of the cannula such that it is inserted in a desired position.
In the second configuration, the cross-sectional area of the portion of the channel is smaller and the trocar cannula is fixed in position. Accordingly, the trocar cannula is prevented from moving in the longitudinal direction (and in any direction).
The trocar fixation assembly allows for a trocar cannula to be fixed in a position very close to the skin surface, which is beneficial during e.g. hernia repair surgery.
Since no part of the trocar fixation assembly remains inside the body (as is the case with balloon trocars) or requires fixation by means of sutures to the skin (as is the case with Hasson trocars), the trocar fixation assembly provides a safe and simplified means to fixate a trocar in position during minimal invasive surgery. Furthermore, the attachment and detachment of the trocar fixation assembly is significantly facilitated.
The trocar is prevented from moving into and out of the body cavity during surgery. Such movement is undesired since moving the trocar too deep into the body cavity may be harmful to the patient. Furthermore, if the trocar slips out of the body cavity during surgery, this may result in failure of the MIS procedure.
Even though the trocar fixation assembly of the present disclosure is not limited to a particular trocar or a particular cannula, the trocar fixation assembly is particularly beneficial for trocars with cannulas having a smooth outer surface. Such cannulas have an enhanced tendency to slide into and out of the body cavity during surgery.
In exemplary embodiments, the second configuration is a relaxed configuration and wherein the first configuration is a retracted configuration.
The relaxed configuration may also be referred to as the “closed” or “locked” configuration, in which the trocar is fixed in position.
The retracted configuration may be referred to as the “open” configuration, in which the trocar is movable in the longitudinal direction.
The shifting from the second, relaxed configuration to the first, retracted configuration typically requires a force, e.g. a pushing or a clamping force.
In exemplary embodiments, the fixation device comprises locking means configured to move the fixation device between the first and the second configurations.
In exemplary embodiments, the locking means comprises a spring member.
The annular member comprises interior walls and exterior walls, wherein the spring member may be a spring wire encircling at least a portion of the interior walls of the annual member.
In the second, relaxed configuration, at least a portion of the spring wire projects radially from the interior walls into the channel. Accordingly, a trocar cannula is prevented from being inserted into the channel. However, once inserted, the spring wire secures that the trocar is fixed in position by a clamping mechanism. Hence, in the portion of the channel where the spring wire is arranged, the cross-sectional area is smaller than the cross-sectional area of the remaining portions of the channel.
In the first, retracted configuration, the spring wire is retracted against the interior walls of the annular member. Accordingly, the cross-sectional area of the portion of the channel where the spring wire is arranged may correspond to the cross-sectional area of the remaining portions of the channel.
It is, however, conceivable that the spring wire is wound around the entire interior walls of the annular member. Nevertheless, the cross-sectional area of at least one portion of the channel in the second, relaxed configuration will be smaller than the cross-sectional area in the same portion of the channel in the first configuration.
The spring wire may be operably engaged with at least a first locking tab, wherein the first locking tab projects radially from the exterior walls of the annular member.
The surgeon may easily grasp the first locking tab during insertion and positioning of the trocar at a surgical incision.
The first locking tab may be movable between a first position and a second position, wherein the movement of the first locking tab from the first to the second position causes the spring wire to retract such that the fixation device is moved from the second to the first configuration
The movement of the first locking tab between a first and a second position causes the spring wire to retract such that the fixation device adopts the first, open configuration. After the trocar has been fixed in position, the surgeon may simply release the tab, such that that trocar is “clamped” in the fixed position by means of the spring member
In exemplary embodiments, a distal end of the spring wire spring is connected to or forms part of the first locking tab.
The spring wire typically has two distal ends. A first distal end may be connected to or form part of the first locking tab. The second distal end may be positioned against the interior walls and may be utilized to anchor the spring wire to the interior walls of the annular member.
For example, the annular member may comprise a slot to connect the first distal end of the spring wire to the first locking tab projecting from the exterior walls of the channel.
In exemplary embodiments, the annular member comprises a second locking tab projecting radially from the exterior walls of the annular member, wherein the first locking tab is moveable in a circumferential direction with respect to the second locking tab.
The second locking tab facilitates the shifting between the first and the second positions. The operator may grasp the first and the second tabs with his/her fingers and by moving the first locking tab towards the second locking tab in a circumferential direction, i.e. along part of the circumference of the annular member, the spring member, e.g. spring wire retracts.
In exemplary embodiments, the medical dressing comprises a centrally disposed aperture configured to encircle the annular member.
The medical dressing typically encircles the annular member such that no gaps are formed between the medical dressing and the fixation device. This is to prevent potential entry of contaminants. The parts of the medical dressing surrounding the annular member of the fixation device may be adhesively attached to the skin of a patient.
In exemplary embodiments, the medical dressing extends uninterrupted around the annular member.
A tight seal is thereby provided, and the sterility is improved in the area circumventing the surgical site.
In exemplary embodiments, the medical dressing comprises a backing layer and an adhesive skin contact layer.
The adhesive skin contact layer secures a tight fit to the skin, and the dressing is fixed in place in the area circumventing the surgical site. Blood and body fluids exuded from the surgical site may be evaporated through the backing layer.
In exemplary embodiments, the adhesive skin contact layer comprises a silicone based adhesive.
A silicone based adhesive is skin-friendly and gentle to the skin. The silicone based adhesive allows for the dressing to be removed from the skin in a gentle manner without causing trauma.
In exemplary embodiments, the medical dressing comprises an absorbent pad between the backing layer and the adhesive skin contact layer.
An absorbent pad is beneficial to absorb the blood resulting from the surgical intervention. It is desirable to prevent blood from accumulating at the skin, and instead secure removal and proper handling of the blood by means of the absorbent pad. Accordingly, contaminating microorganisms are prevented from accumulating at the skin, and the sterility is improved.
In exemplary embodiments, the absorbent pad comprises a polyurethane foam.
A polyurethane foam is beneficial since it is capable of absorbing large amounts of fluids, and also has a pressure relieving effect. The pressure relieving effect is beneficial to prevent pressure ulcers from occurring. A dressing comprising a polyurethane foam is also conformable.
According to another aspect, there is provided a trocar system comprising a trocar fixation assembly according to any one of the preceding claims and a trocar.
In exemplary embodiments, the trocar comprises a cannula, wherein the cannula comprises an interior surface and an exterior surface, wherein the exterior surface of the cannula is smooth.
The trocar fixation assembly of the present disclosure is particularly beneficial for trocar cannulas having a smooth surface since these have an enhanced tendency to dislocate into and out of the body cavity during surgery.
Further features of, and advantages with, the present disclosure will become apparent when studying the appended claims and the following description. The skilled addressee realizes that different features of the present disclosure may be combined to create embodiments other than those described in the following, without departing from the scope of the present disclosure.
The various aspects of the present disclosure, including its particular features and advantages, will be readily understood from the following detailed description and the accompanying drawings, in which:
The present disclosure will now be described more fully hereinafter with reference to the accompanying drawings, in which currently preferred embodiments of the present disclosure are shown. The present disclosure may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided for thoroughness and completeness, and fully convey the scope of the present disclosure to the skilled person. Like reference characters refer to like elements throughout.
With reference to
The trocar fixation assembly has been attached to the skin 109 of a patient. An incision allowing for the entry of a trocar may be made before or after the trocar fixation assembly has been attached to the skin 109.
With reference to
As used herein, the term “trocar fixation assembly” means an assembly comprising at least a fixation device and a medical dressing. The medical dressing may be fixedly or detachably attached to the fixation device. The medical dressing is typically arranged to extend around the contour of the fixation device and to be arranged in contact with the skin of the patient. The trocar fixation assembly is to be used in conjunction with a trocar. More particularly, the trocar fixation assembly is used to receive and engage with a trocar cannula.
As used herein, the term “trocar” means a device through which a minimal invasive surgery can be accomplished. The trocar typically comprises at least a cannula; i.e. a hollow tube shaped member, and a gas-tight valve. The trocar allows for the entry of surgical instruments, such as graspers, scissors, staplers, cameras etc.
The “annular member” is an annular; i.e. ring-shaped element defining a channel. The channel defined by the annular member has a circular cross-section. The first annular member typically extends uninterrupted around the channel. Accordingly, the first annular member forms a closed path around the channel and is not openable. The annular member may be arranged in contact with the skin of a patient. Alternatively, it may be connected to a skin-attachment element that is arranged in contact with the skin. The annular member is not limited to a particular material but may comprise any skin compatible or skin friendly material. For example, the first annular member may comprise a plastic material.
In the second configuration of the fixation device, the cross-sectional area of at least one portion of the channel may be from 5 to 20%, e.g. from 10-15% smaller than the cross-sectional area of that portion of the channel in the first configuration
The second configuration of the fixation device may be a relaxed configuration and wherein the first configuration may be a retracted configuration.
As used herein, the term “relaxed configuration” means the configuration that the fixation device has in the absence of a force exerted on the fixation device, e.g. a pushing, clamping or retraction force. The relaxed configuration may also be referred to as a “closed” or “locked” configuration. This is the configuration that the trocar fixation assembly has prior to insertion of a trocar.
As used herein, the term “retracted configuration” means the configuration has that the fixation device has when subjected to a force, e.g. a pushing, clamping or retraction force. The retracted configuration may also be referred to as an “open” configuration.
The trocar fixation assembly 100 of the present disclosure allows for a trocar to be fixed in a safe and skin friendly manner compared to e.g. conventional Hasson or balloon trocars. No parts of the trocar fixation assembly reside inside the body cavity (e.g. no sutures or balloon), and the attachment and detachment of the trocar fixation assembly is significantly facilitated.
The second, relaxed configuration also allows for a trocar cannula to be fixed at a minimal distance from the skin, which may be desirable during e.g. hernia repair surgery.
The fixation device 101 may comprise locking means configured to move the fixation device between the first and the second configurations.
Typically, the locking means comprises a spring member 106.
As best illustrated in
As illustrated in
As illustrated in
The spring wire 106 may be operably engaged with at least a first locking tab 107b. As illustrated in e.g.
As best illustrated in
The distal end 116 of the spring wire connected to or forming part of the first locking tab 107a may be referred to as a “first distal end”.
The second distal end 117 of the spring wire may be utilized to anchor the spring wire 106 at the interior walls 108a of the annular member 103. As illustrated in
In the area where the spring wire is arranged, the interior walls 108a may comprise one or more annular indentations (see 115 in e.g.
The spring wire may be wound at least one lap along the perimeter of the interior walls 108a of the annular member 103. It is also conceivable that the spring wire is wound a plurality of laps along the perimeter of the interior walls 108a of the annular member 103. The spring member may, in alternative embodiments be a spring coil. Accordingly, the spring member is wound around the entire interior walls 108a of the annular member 103.
The first locking tab 107a may be easily accessed and grasped by an operator.
As best illustrated in
With reference to e.g.
Furthermore, the circumferentially extending slot 118 allows for the spring member to move between the first and the second positions.
Accordingly, the first locking tab 107a may be movable in a circumferential direction of the annular member 103 (see arrow 113 in
In embodiments, the annular member 103 comprises a second locking tab 107b projecting radially from the exterior walls 108b of the annular member 103, wherein the first locking tab 107a is moveable in a circumferential direction with respect to the second locking tab 107b. Accordingly, the first locking tab 107a may be moved along a portion of the circumference of the annular member 103.
The second locking tab 107b may or may not be movable.
In the embodiment illustrated in the figures, the second locking tab 107b is a fixed tab. Accordingly, it is not moveable in any direction. Instead, the second locking tab 107b serves as a support to facilitate the movement of the first locking tab between the first and the second positions in order to facilitate shifting between the first, and the second configurations of the fixation member 101.
The second locking tab 107b projects radially from the exterior surface of the annular member 103. The operator may easily grasp the first 107a and second 107b locking tabs by his/her thumb and forefinger to shift between the first, and the second configurations of the fixation device 101.
As illustrated in
The channel 104 of the annular member has a circular cross-section and may have a diameter that matches or is slightly larger than the diameter of a trocar cannula. This is to allow for a trocar cannula to slide in the longitudinal direction. For example, the diameter of the channel may be in the range of from 4 to 15 mm, e.g. from 5 to 12 mm.
In the first, open configuration, the diameter, d2, of the portion of the channel where the spring wire is arranged may correspond to the diameter of the remaining portions of the channel in the open configuration.
The diameter, d2, of the portion of the channel 104 in the first configuration may be at least 5%, e.g. between 5 and 10% larger than the diameter, d1, of the same portion of the channel 104 in the second configuration.
In the second configuration of the fixation device, the cross-sectional area of at least one portion of the channel where the spring wire is arranged may be from 5 to 20%, e.g. from 10-15% smaller than the cross-sectional area of that portion of the channel in the first configuration
As illustrated in e.g.
The diameter of the aperture 119 generally corresponds to the perimeter of the annular member 103. Accordingly, no gaps are formed between the fixation device 101 and the medical dressing 102. This is desirable to prevent the entry of contaminating microorganisms.
The annular member 103 may, in embodiments, be connected to or form part of a skin-attachment member 120.
The skin-attachment member 120 may, in embodiments, comprise a second annular member 121. The skin-attachment member 120 may form part of the fixation device 101. The (first) annular member 103 may be configured to mate with the second annular member 121 of the skin-attachment member 120. The first annular member 103 may be attached to the second annular member 121 by any means, e.g. by means of an adhesive or by means of welding.
The skin-attachment member 120 may further comprise a base member 122 arranged in contact with the skin of a patient. Alternatively, the annular member 103, which may also be referred to as a first annular member, is arranged in contact with the skin.
The second annular member 121 may comprise walls extending from a bottom surface to a top surface. The base member 122 may surround the bottom surface of the second annular member 121. The base member 122 may be configured to extend radially around the bottom surface of the annular member 103. The base member 122 has a larger surface area than the surface area of the second annular member 121.
The base member 122 may be formed integrally with the second annular member 121. The base member 122 is not limited to a particular shape, but is in
In use, at least a portion of the medical dressing may overlie the base member 122 of the skin attachment member 120.
As illustrated in
The medical dressing 102 is illustrated as a circular dressing in the figures. However, the medical dressing is by no means limited to a specific shape, but any shape is conceivable. It is also conceivable that the surgical staff may cut the dressing into a shape specifically adapted for a specific surgical intervention in an actual surgical scenario.
As best illustrated in
Accordingly, the medical dressing 102 forms a closed path around the first annular member 104. Consequently, no part of the dressing is openable after the dressing has been applied to the skin. This is beneficial to secure a tight seal to the skin and also to prevent contaminants from entering the incision or the area of the skin circumventing the incision.
The medical dressing 102 may be detachably or fixedly attached to the fixation device 101. In embodiments, where the fixation device 101 comprises a skin-attachment member 120, the medical dressing 102 may be detachably or fixedly attached to the skin attachment member 120. For example, the medical dressing 102 may be detachably or fixedly attached to the base member 122 of the skin attachment member 120.
The detachable configuration of the medical dressing 102 allows for each of the components of the trocar fixation assembly to be packed separately such that the surgical staff may assemble the components of the fixation assembly prior to surgery.
In the fixed configuration, the trocar fixation assembly may be packaged as one individual component, which may save time since no assembly step is required prior to surgery.
As illustrated in the zoomed in, cross-sectional view in
The backing layer 110 is an outermost layer of the medical dressing and may also be referred to as a top layer. The backing layer 110 faces away from the patient's body in use.
The backing layer 110 may comprise a polymeric film, e.g. a polyethylene film, a polypropylene film or a polyurethane film. Preferably, the backing layer 110 comprises a polyurethane film. The thickness of the backing layer may be in the range of from 10 to 50 μm, e.g. from 15 to 40 μm.
As used herein, the term “adhesive skin contact layer” means a layer configured to detachably adhere the dressing to a dermal surface. In other words, the adhesive skin contact layer is configured to contact the skin of a wearer.
A release liner being co-extensive with the adhesive skin contact layer 111 is typically detachably attached to the adhesive skin contact layer 111. The release liner prevents contamination of the adhesive skin contact layer 111 and is removed prior to application of the dressing to the skin.
The adhesive skin contact layer may comprise any skin-compatible adhesive.
Preferably, the adhesive skin contact layer 111 comprises a silicone based adhesive.
A silicone-based adhesive is gentle to the skin and may be removed from the skin without causing any trauma. For example, the adhesive skin contact layer 111 may comprise a silicone gel. The silicone gel may be provided as a coating on the backing layer or the absorbent pad, if present.
The adhesive skin contact layer 111 may comprise one or more sub-layers. For example, the adhesive skin contact layer 111 may comprise a polymeric film and an adhesive silicone gel layer, wherein the adhesive silicone gel layer is arranged to contact the skin.
The medical dressing may comprise an absorbent pad 112 between the backing layer 110 and the adhesive skin contact layer 111.
The absorbent pad 112 keeps the area circumventing the incision and the trocar fixation assembly free from blood. The absorbent pad 112 absorbs the blood and prevents maceration at the surgical site. Furthermore, the absorbent pad prevents contaminating microorganisms from accumulating at the skin or incision site.
In embodiments where the dressing comprises an absorbent pad, the backing layer 110 may be adhesively attached to the absorbent pad. Alternatively, the backing layer 110 may be laminated to the absorbent pad. For example, heat lamination may be utilized to apply the backing layer 110 to the absorbent pad.
The absorbent pad 112 preferably comprises a polyurethane foam.
Typically, the polyurethane foam is a hydrophilic polyurethane foam.
A polyurethane foam has a pressure relieving effect and is capable of absorbing large amounts of fluids
The absorbent pad 110 may comprise one or more layers. If the absorbent pad comprises a plurality of pad-forming layers, the pad-forming layers may be laminated or attached to each other to facilitate cutting through the dressing.
The medical dressing may be a so-called bordered dressing. The backing layer and the adhesive skin contact layer may be configured to extend beyond the contour of the absorbent pad.
Accordingly, the absorbent pad is centrally disposed between the backing layer and the adhesive skin contact layer. In this regard, the absorbent pad is arranged in close vicinity of the surgical site. The border portion of the dressing formed by the backing layer and the adhesive skin contact layer overlapping the absorbent pad may provide an improved adhesion to the skin of a patient, thereby enhancing the stay-on ability of the medical dressing.
According to another aspect, there is provided a trocar system comprising a trocar fixation assembly 100 as described hereinbefore and a trocar 200.
The trocar system may be packaged and distributed in a unit such that the surgical staff does not need to assemble the trocar system prior to surgery.
Alternatively, the trocar fixation assembly, and the trocar, respectively, are packaged separately and assembled prior to use.
As illustrated in e.g.
The cannula is typically a hollow tube that serves as channel for the insertion of surgical tool. The cannula may be made of plastic or metal. The cannula may comprise a gas-tight valve 203 that provides for an internal air-seal allowing instruments to move in and out of the cannula without loss of pneumoperitoneum; i.e. gas present in the body cavity. The valve may be manually or automatically retractable during instrument passage.
The cannula 201 typically comprises an interior surface and an exterior surface 202. The exterior surface 202 of the cannula 201 may comprise ridges or threads or may be smooth. In the context of the present disclosure, a cannula 201 having a smooth exterior surface 202 is generally preferred.
The tip 204 of the cannula may be conical, blunt, eccentric or pyramidal to facilitate penetration and entry into a body cavity.
Even though the present disclosure has been described with reference to specific exemplifying embodiments thereof, many different alterations, modifications and the like will become apparent for those skilled in the art.
Variations to the disclosed embodiments can be understood and effected by the skilled addressee in practicing the present disclosure, from a study of the drawings, the disclosure, and the appended claims. Furthermore, in the claims, the word “comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality.
| Number | Date | Country | Kind |
|---|---|---|---|
| 21210491.3 | Nov 2021 | EP | regional |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2022/081461 | 11/10/2022 | WO |
