Flexible cannula with selective stiffness

The surgical access device with a fluid-controlled tubular member addresses the limitations of minimally invasive surgery by providing flexible insertion and rigid stabilization, improving access and maneuverability in minimally invasive procedures.

JP7734017B2Active Publication Date: 2025-09-04COVIDIEN LP
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Patent Information

Application Number
JP2021127292
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2020-08-17
Filing Date
2021-08-03
Publication Date
2025-09-04
Estimated Expiration
2041-08-03

AI Technical Summary

Technical Problem

Minimally invasive surgical procedures are limited by the use of small incisions, restricting the use of long, narrow instruments and the need to maintain the body cavity in an insufflated state, which complicates instrument manipulation and access to internal surgical sites.

Method used

A surgical access device with a tubular member featuring a conduit transitionable between flexible and fixed states, controlled by fluid presence in an annular lumen, allowing manipulation and stabilization through fluid management.

Benefits of technology

Enables flexible insertion and rigid stabilization of surgical instruments, enhancing access and maneuverability to internal surgical sites while maintaining insufflation.

✦ Generated by Eureka AI based on patent content.

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Abstract

To provide a flexible cannula having selective rigidity.SOLUTION: A surgical access device includes a housing having a tubular member extending from the housing. The tubular member has inner and outer walls defining an annular lumen between the inner and outer walls. A passageway extends between proximal and distal openings of the tubular member. The passageway is configured to receive a surgical instrument therethrough. A conduit is disposed in the annular lumen and includes spiral segments where each spiral segment is engaged with an adjacent spiral segment. The conduit is flexible in a first state and is fixed in a second state. A valve assembly is coupled to the housing and includes a port that is in fluid communication with the annular lumen. The port is attachable to a source of fluid.SELECTED DRAWING: None
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Description

[Technical Field]

[0001] The present disclosure relates generally to surgical instruments for minimally invasive surgery. Specifically, the present disclosure relates to a flexible cannula having selective stiffness. [Background technology]

[0002] Minimally invasive surgical procedures are procedures in which a surgeon enters a patient's body through small openings in the patient's skin or natural orifices (e.g., mouth, anus, vagina). Compared to traditional open surgery, minimally invasive surgical procedures have several advantages and disadvantages. Minimally invasive surgical procedures include arthroscopic, endoscopic, laparoscopic, and thoracoscopic procedures. In laparoscopic and endoscopic surgical procedures, small incisions or punctures are made in the patient's body (e.g., abdomen) to provide entry points for surgical access devices. The surgical access devices are inserted into the incisions to facilitate the insertion of instruments used to perform the surgical procedure within the internal surgical site. Minimally invasive surgical procedures are advantageous compared to traditional open surgical procedures in that the incisions made through the patient's body are relatively small, thereby reducing both trauma to the patient and recovery time. However, because these incisions are small, only long, narrow, small-diameter instruments can be used to access body cavities and organs.

[0003] During such procedures, surgical objects, such as surgical access devices (e.g., cannulas), are inserted into the patient's body through an incision in tissue. Typically, prior to introducing the surgical objects into the patient's body, insufflation gas is used to expand the area around the target surgical site, creating a larger, more accessible working area. The surgeon can then perform the procedure within the abdominal cavity by manipulating instruments extended through the access device. Manipulating such instruments inside the body is similarly limited by both space constraints and the need to maintain the body cavity in an insufflated state. Summary of the Invention [Means for solving the problem]

[0004] The surgical access device includes a housing and a tubular member extending from the housing. The tubular member has a proximal opening and a distal opening and includes an outer wall and an inner wall, the outer wall and the inner wall defining an annular lumen therebetween. A passageway extends between the proximal opening and the distal opening and is configured to receive a surgical instrument therein. A conduit extends along the length of the tubular member and is disposed within the annular lumen. The conduit is transitionable between a first state and a second state. The conduit includes helical segments, each helical segment engaged with an adjacent helical segment such that the conduit has a flexible configuration in the first state and a fixed configuration in the second state. A valve assembly is coupled to the housing and includes a port in fluid communication with the annular lumen and attachable to a fluid source.

[0005] In one aspect, the fluid may be disposed in the annular lumen.

[0006] In another embodiment, the conduit may transition to the first state in the presence of fluid within the annular lumen.

[0007] In a further embodiment, the conduit may transition to the second state in the absence of fluid within the annular lumen.

[0008] In another embodiment, each helical segment can have a first portion and a second portion, each of which can have a generally C-shaped cross-sectional configuration.

[0009] In one aspect, the first portion of each helical segment may be slidable relative to the second portion of the adjacent helical segment such that the conduit is in the first state.

[0010] In one aspect, the first portion of each helical segment can be fixed relative to the second portion of the adjacent helical segment such that the conduit is in the second state.

[0011] In another aspect, the tubular member may be flexible and adapted to receive a flexible surgical instrument therein.

[0012] In one aspect, the inner and outer walls of the annular lumen may contact the surface of the helical segment of the conduit.

[0013] A method of accessing a surgical site includes positioning a tubular member of a surgical access device through an opening in tissue, directing a distal portion of the tubular member toward the target site, manipulating the tubular member to follow a predetermined path while the tubular member is in a first state, and removing fluid from an annular lumen defined between inner and outer walls of the tubular member, thereby transitioning the tubular member from the first state to a second state in which the tubular member is rigid.

[0014] In one aspect, manipulating the tubular member can include manipulating a conduit disposed in the annular lumen of the tubular member.

[0015] In another aspect, manipulating the conduit may include manipulating a helical segment of the conduit such that a first section of one helical segment slidably engages with a second section of an adjacent helical segment.

[0016] In a further aspect, removal of fluid from the annular lumen may cause the inner and outer walls of the lumen to contact the surfaces of the helical segment of the conduit.

[0017] In yet another aspect, removal of fluid from the annular lumen can cause a first section of a helical segment of a conduit disposed within the annular lumen to become fixed relative to a second section of an adjacent helical segment of the conduit, thereby defining a second state of the tubular member.

[0018] In one aspect, the method can include inserting a flexible surgical instrument through the tubular member while the tubular member is in the first condition.

[0019] In a further aspect, removing fluid from the annular lumen can include operating a valve on a housing coupled to the proximal end of the tubular member.

[0020] In yet another aspect, the method may include introducing a fluid into the annular lumen, thereby transitioning the tubular member from the second state to the first state, and may include removing the tubular member from the opening in the tissue.

[0021] In one aspect, introducing a fluid into the annular lumen can include operating a valve on a housing coupled to the proximal end of the tubular member. The present disclosure provides, for example: (Item 1) 1. A surgical access device comprising: The housing and a tubular member extending from the housing, the tubular member having a proximal opening and a distal opening, the tubular member including an outer wall and an inner wall, the outer wall and the inner wall defining an annular lumen therebetween; a passageway extending between the proximal opening and the distal opening, the passageway configured to receive a surgical instrument therein; a conduit extending along the length of the tubular member, the conduit being disposed in the annular lumen and being transitionable between a first state and a second state, the conduit including helical segments, each helical segment engaging with an adjacent helical segment such that the conduit has a flexible configuration in the first state and a fixed configuration in the second state; a valve assembly coupled to the housing and including a port, the port in fluid communication with the annular lumen and attachable to a fluid source. (Item 2) 10. The surgical access device of claim 1, further comprising a fluid disposed within the annular lumen. (Item 3) 10. The surgical access device of claim 1, wherein the conduit transitions to the first state when fluid is present within the annular lumen. (Item 4) 10. The surgical access device of claim 1, wherein the conduit transitions to the second state when the fluid is not present in the annular lumen. (Item 5) 10. The surgical access device of claim 1, wherein each spiral segment has a first portion and a second portion, and each of the first portion and the second portion has a generally C-shaped cross-sectional configuration. (Item 6) 10. The surgical access device of claim 1, wherein the first portion of each spiral segment is slidable relative to the second portion of the adjacent spiral segment so that the conduit is in the first state. (Item 7) 10. The surgical access device of claim 1, wherein the first portion of each spiral segment is fixed relative to the second portion of the adjacent spiral segment such that the conduit is in the second state. (Item 8) 10. The surgical access device of claim 1, wherein the tubular member is flexible and adapted to receive a flexible surgical instrument therein. (Item 9) 10. The surgical access device of claim 1, wherein the inner and outer walls of the annular lumen contact a surface of the helical segment of the conduit. (Item 10) 1. A method of accessing a surgical site, comprising: Positioning a tubular member of a surgical access device through an opening in tissue; directing a distal portion of the tubular member toward a target site; manipulating the tubular member to follow a predetermined path while the tubular member is in a first state; removing fluid from an annular lumen defined between an inner wall and an outer wall of the tubular member, thereby transitioning the tubular member from the first state to a second state in which the tubular member is rigid. (Item 11) 10. The method of claim 1, wherein manipulating the tubular member comprises manipulating a conduit disposed in the annular lumen of the tubular member. (Item 12) 10. The method of claim 9, wherein manipulating the conduit includes manipulating a helical segment of the conduit such that a first section of one helical segment slidably engages a second section of an adjacent helical segment. (Item 13) 10. The method of claim 9, wherein removing fluid from the annular lumen causes the inner and outer walls of the lumen to contact surfaces of the helical segment of the conduit. (Item 14) 10. The method of claim 9, wherein removing fluid from the annular lumen causes a first section of a helical segment of a conduit disposed within the annular lumen to become fixed relative to a second section of an adjacent helical segment of the conduit, thereby defining the second state of the tubular member. (Item 15) 2. The method of claim 1, further comprising inserting a flexible surgical instrument through the tubular member while the tubular member is in the first condition. (Item 16) 10. The method of claim 1, wherein removing fluid from the annular lumen comprises operating a valve on a housing coupled to a proximal end of the tubular member. (Item 17) introducing a fluid into the annular lumen, thereby transitioning the tubular member from the second state to the first state; The method of any of the preceding items, further comprising removing the tubular member from the opening in the tissue. (Item 18) 10. The method of claim 1, wherein introducing a fluid into the annular lumen comprises operating a valve on a housing coupled to a proximal end of the tubular member. (Item 19) 1. A system for accessing a surgical site, comprising: a surgical access device comprising a tubular member; the tubular member is configured to be positioned through an opening in tissue; the tubular member includes a distal portion configured to be guided toward a target site; the tubular member includes an inner wall and an outer wall, the inner wall and the outer wall defining an annular lumen therebetween, the tubular member being transitionable between a first state and a second state; While the tubular member is in a first state, the tubular member is manipulated to follow a predetermined path; the tubular member is rigid in the second state; The system, wherein removal of fluid from the annular lumen transitions the tubular member from the first state to the second state. (Item 20) 10. The system of claim 1, wherein the surgical access device further comprises a conduit disposed within the annular lumen of the tubular member. (Item 21) 10. The system of claim 9, wherein the conduit includes spiral segments, the spiral segments being manipulated in a manner such that a first section of one spiral segment slidably engages with a second section of an adjacent spiral segment. (Item 22) 10. The system of claim 1, wherein the removal of fluid from the annular lumen causes the inner and outer walls of the lumen to contact surfaces of a helical segment of a conduit disposed within the annular lumen. (Item 23) The system of any preceding item, wherein the removal of fluid from the annular lumen causes a first section of a helical segment of a conduit disposed in the annular lumen to become fixed relative to a second section of an adjacent helical segment of the conduit, thereby defining the second state of the tubular member. (Item 24) 10. The system of claim 1, further comprising a flexible surgical instrument configured to be inserted through the tubular member while the tubular member is in the first condition. (Item 25) 10. The system of claim 1, wherein the surgical access device further comprises a housing and a valve on the housing, the valve coupled to a proximal end of the annular member, the valve operable to remove fluid from the annular lumen. (Item 26) introducing a fluid into the annular lumen causes the tubular member to transition from the second state to the first state; 10. The system of claim 1, wherein the annular member is further configured to be removed from the opening in tissue. (Item 27) 10. The system of claim 1, wherein the surgical access device further comprises a housing and a valve on the housing, the valve coupled to a proximal end of the annular member, the valve operable to introduce fluid into the annular lumen. (Summary) The surgical access device includes a housing having a tubular member extending therefrom. The tubular member has an inner wall and an outer wall, the inner wall and the outer wall defining an annular lumen therebetween. A passageway extends between a proximal opening and a distal opening of the tubular member. The passageway is configured to receive a surgical instrument therethrough. A conduit is disposed in the annular lumen and includes helical segments, each helical segment engaging with an adjacent helical segment. The conduit is flexible in a first state and fixed in a second state. A valve assembly is coupled to the housing and includes a port in fluid communication with the annular lumen. The port is attachable to a fluid source.

[0022] Other features of the present disclosure will be understood from the following description. [Brief explanation of the drawings]

[0023] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate aspects and features of the present disclosure and, together with the following detailed description, serve to further explain the disclosure.

[0024] [Figure 1] FIG. 1 is a perspective view of a surgical access device with a housing and a tubular member in a first state according to one embodiment of the present disclosure. [Figure 1A] 1A is a cross-sectional view of the housing and the proximal region of the tubular member taken along section line 1A-1A of FIG. 1. [Figure 2] FIG. 2 is a perspective view of a distal portion of a tubular member of the surgical access device of FIG. 1, with the conduit shown in phantom. [Figure 3] FIG. 3 is a perspective view of the conduit of FIG. 2. [Figure 4] FIG. 4 is an enlarged view of the indicated area of ​​detail in FIG. 3. [Figure 5] 5 is a side cross-sectional view of the distal portion of the tubular member taken along section line 5-5 of FIG. 2. [Figure 6] 2 is a side view of the tubular member of the surgical access device of FIG. 1 in a second condition. [Figure 7] FIG. 7 is a side cross-sectional view taken along section line 7-7 of FIG. 6. [Figure 8] 2 is a side view of the surgical access device of FIG. 1 with the tubular member inserted into tissue in a second position. DETAILED DESCRIPTION OF THE INVENTION

[0025] Embodiments of the present disclosure are described below with reference to the accompanying drawings. However, it should be understood that the disclosed embodiments are merely exemplary of the present disclosure and may be embodied in various forms. Well-known functions or structures are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, the specific structural and functional details disclosed herein should not be construed as limiting, but merely as a basis for the claims and as a representative basis for teaching those skilled in the art how to vary the present disclosure to substantially any suitable detailed structure.

[0026] The description of the technical features of one aspect of the present disclosure should be considered as generally applicable and applicable to other similar features of another aspect of the present disclosure. Therefore, the technical features described in this specification according to one aspect of the present disclosure may be applicable to other aspects of the present disclosure, and therefore, redundant descriptions may be omitted in this specification. Similar reference numerals may refer to similar elements throughout the specification and drawings.

[0027] 1 and 1A, a surgical access device in accordance with the present disclosure is illustrated and identified as surgical access device 100. Surgical access device 100 has a housing 10 and a tubular member 20 extending therefrom. Tubular member 20 is an elongated structure formed from a suitable biocompatible polymeric material (e.g., silicone rubber or ethylene propylene diene monomer (EPDM) rubber) and has a proximal opening 20a and a distal opening 20b defining a passageway 28 extending therebetween. The polymeric material used for tubular member 20 allows tubular member 20 to be flexible in multiple directions, thereby enabling multiple configurations for tubular member 20. Housing 10 includes an upper housing 12 releasably coupled to a lower housing 14. Tabs 16 extend radially from lower housing 14 and are operable to permit relative rotation between upper and lower housings 12, 14. Relative rotation between the upper and lower housings 12, 14 allows the upper and lower housings 12, 14 to be coupled together or separated from one another. The lower housing 14 has a frustoconical region 18 with a tubular member 20 extending therefrom. A valve assembly 30 extends laterally from the frustoconical region 18 and is attachable to a fluid source "FS" via flexible tubing 36. The housing 10 is coaxial with the proximal opening 20a of the tubular member 20 and has a channel 15 extending therethrough. Examples of suitable housings are disclosed in commonly owned U.S. Pat. No. 10,022,149 to Holsten et al. and U.S. Patent Application Publication No. 2015 / 0031958 to Kleyman, the contents of which are incorporated herein by reference in their entireties.

[0028] Fluid source "FS" may provide pressurized fluid to annular lumen 26 of tubular member 20 and / or may provide a vacuum to annular lumen 26 of tubular member 20. Referring briefly to FIG. 5 , annular lumen 26 is defined between outer wall 24 and inner wall 22 of the tubular member. Fluid is introduced into or expelled from annular lumen 26 through valve assembly 30. Valve assembly 30 includes port 32 and valve 34, such as a stopcock valve. When valve 34 is in an open position, it allows fluid to flow between annular lumen 26 and port 32, while when valve 34 is in a closed position, it isolates port 32 from annular lumen 26. Valve assembly 30 fits into receiver 17 in frustoconical region 18 of lower housing 14, thereby defining chamber 19 between a bottom surface of valve assembly 30 and a bottom surface of receiver 17. Annular lumen 26 of tubular member 20 is fluidly coupled to chamber 19 of receiver 17 via tunnel 21. In this arrangement, opening valve 34 allows fluid to flow into or out of annular lumen 26. Similarly, closing valve 34 prevents fluid from flowing into or out of annular lumen 26.

[0029] Referring now to FIG. 2, a portion of the tubular member 20 is shown in a first state. Disposed within the tubular member 20 is a hose or conduit 40 wound into a strip. The conduit 40 is formed from a biocompatible metal (e.g., stainless steel). As seen in FIGS. 3 and 4, the conduit 40 includes interlocking spiral segments 42 wound helically between the proximal and distal openings 20a, 20b of the tubular member 20. Each spiral segment 42 includes a first portion 44 and a second portion 46. With further reference to FIG. 5, the first portion 44 of each spiral segment 42 includes a first flange 44a and a first trough 44b, and the second portion 46 of each spiral segment 42 includes a second flange 46a and a second trough 46b. The partition 45 connects the first trough 44b and the second trough 46b and extends perpendicular to the first trough 44b and the second trough 46b. Thus, the cross-section of the helical segment 42 has a square wave pattern. The first flange 44a is slidably disposed within the second trough 46b, and the second flange 46a is slidably disposed within the first trough 44b. In the first state of the tubular member 20, the helical segments 42 of the conduit 40 are free to move relative to one another. Thus, when manipulated by a surgeon, the first flange 44a slides within the second trough 46b, and the second flange 46a slides within the first trough 44b, allowing the surgeon to manipulate the tubular member 20 and the conduit 40 to achieve a specific orientation that follows a desired path through body tissue.

[0030] 5 , as described above, the inner wall 22 and outer wall 24 of the tubular member 20 define an annular lumen 26 therebetween. The annular lumen 26 extends from the proximal end of the tubular member 20 to the distal end of the tubular member 20. The annular lumen 26 has a closed distal end. When the valve 34 of the valve assembly 30 is in a closed configuration, the annular lumen 26 has a fluid-tight configuration. A conduit 40 is disposed within the annular lumen 26. When the annular lumen 26 is filled with a fluid (e.g., sterile saline, CO2, or air), the inner wall 22 and outer wall 24 move away from one another, defining a gap between the conduit 40 and the inner wall 22 and outer wall 24. In this flexible configuration (i.e., first state), the tubular member 20 including the conduit 40 has multiple degrees of freedom and can be bent and connected into various configurations, allowing the tubular member 20 to follow a desired path through tissue to reach a target site.

[0031] 6 and 7, a second condition of the tubular member 20 is illustrated. By draining or removing fluid from the annular lumen 26, the inner and outer walls 22 and 24 defining the annular lumen 26 move toward each other in the direction of arrow "A," compressing the conduit 40 between the inner and outer walls 22 and 24, thereby eliminating any gaps between the conduit 40 and the inner and outer walls 22 and 24. Compressing the helical segment 42 of the conduit 40 between the inner and outer walls 22 and 24 of the annular lumen 26 causes the flanges 44a, 46a to frictionally engage with the troughs 44b, 46b. In particular, the first flange 44a frictionally engages the second trough 46b, and the second flange 46a frictionally engages the first trough 44b. In this manner, each helical segment 42 of the conduit 40 is fixed relative to adjacent helical segments 42 of the conduit 40. This arrangement fixes or mounts the conduit 40, and thus the tubular member 20, in a particular orientation.

[0032] In contrast to the flexible state (i.e., first state) of tubular member 20 shown in Figure 1, a fixed state (i.e., second state) of tubular member 20 is shown in Figure 8. Specifically, tubular member 20 in the second state maintains a desired path through body tissue "T." This fixed path through tissue allows flexible surgical instrument "I" to be inserted through housing 10 and follow the second state of tubular member 20 to reach the target site without deviating from the selected path.

[0033] In use, a surgeon inserts tubular member 20 in the flexible or first state (FIG. 1) through opening "O" in the patient's skin "S" (FIG. 8). The surgeon then manipulates tubular member 20 through tissue "T" to reach the target site. Because tubular member 20 is flexible in the first state, the surgeon can manipulate tubular member 20 as needed to reach the target site, even if the target site is blocked or obstructed by other structures within the body. Once the distal end of tubular member 20 reaches the target site, the surgeon evacuates fluid from annular lumen 26, compressing inner and outer walls 22, 24 of tubular member 20 against helical segments 42 of conduit 40 and transitioning tubular member 20 to the fixed or second state (FIG. 7). In the second state, frictional engagement between flanges 44a, 46a and troughs 44b, 46b of helical segments 42 maintains the shape of conduit 40 (FIG. 7). Tubular member 20 also maintains the same configuration, with conduit 40 disposed within annular lumen 26 of tubular member 20. This allows a surgeon to insert flexible surgical instrument "I" through housing 10 and tubular member 20 to access a target site with flexible surgical instrument "I" (FIG. 8).

[0034] Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting. It is contemplated that elements and features may be combined with other elements and features without departing from the scope of the present disclosure. Likewise, those skilled in the art will recognize additional features and advantages of the present disclosure.

Claims

1. 1. A surgical access device comprising: The housing and a tubular member extending from the housing, the tubular member having a proximal opening and a distal opening, the tubular member including an outer wall and an inner wall, the outer wall and the inner wall defining an annular lumen therebetween; a passageway extending between the proximal opening and the distal opening, the passageway configured to receive a surgical instrument therethrough; and a conduit extending along the length of the tubular member, the conduit being disposed in the annular lumen and being transitionable between a first state and a second state, the conduit including a plurality of helical segments, each helical segment of the plurality of helical segments having a first portion and a second portion, the first portion including a first flange and a first trough, the second portion including a second flange and a second trough, a partition connecting the first trough and the second trough and extending perpendicular to the first trough and the second trough; a conduit, wherein a cross section of each spiral segment has a square wave pattern, the first flange of one spiral segment being slidably disposed within the second trough of an adjacent spiral segment, and the second flange of one spiral segment being slidably disposed within the first trough of an adjacent spiral segment, each spiral segment of the plurality of spiral segments being movable relative to an adjacent spiral segment of the plurality of spiral segments, the conduit having a flexible configuration in the first state and a fixed configuration in the second state; a valve assembly coupled to the housing, the valve assembly including a port, the port in fluid communication with the annular lumen and attachable to a fluid source; A surgical access device comprising:

2. The surgical access device of claim 1 , further comprising a fluid disposed in the annular lumen.

3. The surgical access device of claim 2 , wherein the conduit transitions to the first state in the presence of fluid within the annular lumen.

4. The surgical access device of claim 2 , wherein the conduit transitions to the second state in the absence of the fluid within the annular lumen.

5. A surgical access device as described in claim 1, wherein the cross section of each spiral segment is parallel to an axis along the length of the tubular member.

6. 6. The surgical access device of claim 5, wherein when the conduit is in the first state, the first flange is slidable within the second trough and the second flange is slidable within the first trough.

7. 7. The surgical access device of claim 6, wherein the first flange frictionally engages the second trough when the conduit is in the second state, and the second flange frictionally engages the first trough.

8. The surgical access device of claim 3 , wherein the tubular member is flexible and adapted to receive a flexible surgical instrument therein.

9. The surgical access device of claim 4 , wherein the inner and outer walls of the annular lumen contact surfaces of the plurality of helical segments of the conduit.

Citation Information

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