Implants and introducer devices used in lung access procedures to help prevent pneumothorax

Abstract

An implant for use in a lung access procedure to help prevent pneumothorax includes a tubular body having an inner cavity, a proximal end, and a distal end portion terminating at a distal end. The tubular body has a longitudinal axis and has a sidewall radially surrounding the inner cavity. The sidewall has an outer surface. An anchor member is connected to the tubular body, wherein the anchor member is movable from a contracted state to an expanded state relative to the tubular body. At least one suture is connected to the tubular body, wherein the at least one suture extends from the proximal end of the tubular body in a proximal direction.

Description

[0001] Cross-references to related applications

[0002] none. Technical Field

[0003] The present invention relates to lung access procedures, such as lung biopsies, and more particularly to an implant and introducer device for use in lung access procedures to help prevent pneumothorax. Background Art

[0004] Pneumothorax is a problematic complication of lung biopsy procedures in which air or fluid is allowed to enter the pleural space due to puncture of the parietal and visceral pleura. Pneumothorax, and especially pneumothorax requiring chest tube placement, is a significant concern for clinicians and patients undergoing percutaneous lung biopsy. The incidence of pneumothorax in patients undergoing percutaneous lung biopsy has been reported to range from 9-54%, with an average of approximately 15%. On average, 6.6% of all percutaneous lung biopsies result in pneumothorax requiring chest tube placement, which results in an average hospital stay of 2.7 days.

[0005] Factors that increase the risk of pneumothorax include increased patient age, obstructive lung disease, increased lesion depth, multiple pleural perforations, increased time for the needle to pass through the pleura, and traversal of the fissure. Pneumothorax may occur during the surgical procedure or immediately after surgery, which is why a CT scan of the area is typically performed after the needle is removed. Other less common complications of percutaneous lung biopsy include hemoptysis (coughing up blood), hemothorax (a pleural effusion in which blood accumulates in the pleural cavity), infection, and air embolism.

[0006] What is needed in the art is an implant that can be inserted into the chest wall of a patient via an introducer device, wherein the implant is capable of mechanically creating an airtight seal between the pleural layers prior to a lung biopsy procedure to prevent pneumothorax throughout the lung biopsy procedure. Summary of the invention

[0007] The present invention provides an implant that can be inserted into the chest wall of a patient via an introducer device, wherein the implant is capable of mechanically creating an airtight seal between the pleural layers prior to a lung biopsy procedure to prevent pneumothorax throughout the lung biopsy procedure.

[0008] Generally speaking, a method provided by the present invention comprises and makes implant expand, and this implant has one or more sutures extending proximally.Implant is arranged on coaxial introducer (for example coaxial needle) or is arranged in described coaxial introducer, and the coaxial needle carrying implant is inserted through chest wall and pleural layer to produce access opening.Implant has one or more sutures, and described suture extends out the surface that reaches patient's skin backward by access opening.Once coaxial needle enters lung parenchyma, implant just expands and the suture attached to implant is pulled back, makes the rear edge and / or surface of implant turn and be pulled back to force visceral pleura in the region around access opening upward against parietal pleura, therefore mechanically each pleural layer is sealed together.Then suture is fixed in the appropriate position on patient's skin surface, for example, fixed by adhesive tape, adhesive or suturing, so that the airtight seal between parietal pleura and visceral pleura is kept, and lung access procedure can be performed.

[0009] In one form, the present invention relates to an implant for use in a lung access procedure to help prevent pneumothorax. The implant includes a tubular body having an inner cavity, a proximal end, and a distal end portion terminating at a distal end. The tubular body has a longitudinal axis and has a sidewall radially surrounding the inner cavity. The sidewall has an outer surface. An anchor member is connected to, for example, the distal end portion of the tubular body, wherein the anchor member is movable from a contracted state to an expanded state relative to the tubular body. At least one suture is connected to the tubular body, wherein the at least one suture extends in a proximal direction from the proximal end of the tubular body.

[0010] In another form, the present invention relates to an introducer system for a lung access procedure to help prevent pneumothorax. The introducer system includes an elongated sleeve and an implant. The elongated sleeve has an outer surface and a longitudinal axis. The implant is coaxial with the elongated sleeve. The implant includes a tubular body having an inner cavity, a proximal end, and a distal end portion terminating at a distal end portion. The tubular body has a sidewall that radially surrounds the inner cavity. The sidewall has an outer surface. A portion of the elongated sleeve can slide in the inner cavity of the tubular body. An anchor member is connected to the distal end portion of the tubular body, wherein the anchor member can move from a contracted state to an expanded state relative to the tubular body. At least one suture is connected to the tubular body, wherein the at least one suture extends in a proximal direction from the proximal end of the tubular body.

[0011] One advantage of the present invention is that the implant is able to mechanically create an airtight seal between the pleural layers prior to a lung biopsy procedure. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The above and other features and advantages of the present invention and the manner in which they are achieved will become more apparent, and the present invention will be better understood, by referring to the following description of the embodiments of the present invention taken in conjunction with the accompanying drawings, in which:

[0013] Figure 1 is a perspective view of an introducer system having an introducer device and an implant according to one embodiment of the present invention, the view being enlarged and with a portion of the introducer device cut away;

[0014] Figure 2 yes Figure 1 A stereoscopic view of the implant, with the stylet from Figure 1 The elongated cannula of the introducer device is removed;

[0015] Figure 3 yes Figure 1 A perspective view of an implant in which a portion of the tubular body covered by the anchor sleeve and the valve are depicted by dashed lines;

[0016] Figure 4 is along Figure 3 The plane 4-4-4-4 is intercepted Figure 3 A cross-sectional view of an implant;

[0017] Figure 5 yes Figure 3 A side view of the implant in an expanded state, wherein the anchor sleeve forms a bulge;

[0018] Figure 6 A cross-sectional view depicting a portion of a patient's chest wall and lungs and showing a Figure 1-5 1 , wherein the implant is shown in an expanded state and the implant is pulled back to mechanically seal the pleural layers;

[0019] Figure 7 yes Figure 1-6 A side view of an alternative embodiment of an implant;

[0020] Figure 8 is a perspective view of an introducer device with an implant according to another embodiment of the present invention, the view being enlarged and with a portion of the introducer device cut away;

[0021] Fig. 9 yes Figure 8 A stereoscopic image of the implant;

[0022] Fig.10 yes Figure 8 and 9 A top view of the implant;

[0023] Fig.11 yes Figure 8 and 9 A side view of the implant;

[0024] Fig.12A cross-sectional view depicting a portion of a patient's chest wall and lungs and showing a Figure 8 A stereoscopic view of an introducer device and implant of , wherein the implant is pulled back to mechanically seal the pleural layers;

[0025] Fig.13 is a perspective view of an implant according to another embodiment of the present invention to be received in an outer sleeve to retract a retractable anchor member having a plurality of retractable engagement members;

[0026] Fig.14 yes Fig.13 A front view of an implant of , the retraction slot of the tubular body being depicted by a dotted line;

[0027] Fig.15 is a side view of an implant according to another embodiment of the present invention, wherein the implant is in a collapsed state;

[0028] Fig.16 yes Fig.15 a stereoscopic image of an implant of FIG. 1 , wherein the implant is in an expanded state; and

[0029] Fig.17 yes Fig.15 A side view of an implant of FIG. 1 , wherein the implant is in an expanded state.

[0030] Corresponding reference characters indicate corresponding parts throughout the several views.The exemplifications set out herein illustrate some embodiments of the invention and such exemplifications are not intended to limit the scope of the invention in any way. DETAILED DESCRIPTION

[0031] Referring now to the drawings, and more particularly to Figure 1 and 2 , which shows an embodiment of an implant 10 for use in a lung access procedure to help prevent pneumothorax according to the present invention, wherein the implant 10 is shown arranged on an introducer device 12.

[0032] In this embodiment, the introducer device 12 is in the form of a coaxial arrangement of a stylet 16 having a longitudinal axis 18 and an elongated cannula 14. Figure 2 As best shown in FIG. 1 , the elongated cannula 14 has an inner lumen 14-1, an outer surface 14-2, and a beveled distal end 14-3. Figure 1As shown in , the stylet 16 may be in the form of an elongated trocar having a puncture tip portion 16-1. The stylet 16 is slidably received in the lumen 14-1 of the elongated cannula 14 and is sized so that the puncture tip portion 16-1 extends distally beyond the chamfered distal end 14-3 of the elongated cannula 14. The puncture tip portion 16-1 may include a plurality of concave ground surfaces that terminate distally in a pointed tip.

[0033] Also refer to Figure 3-5 , the implant 10 comprises a tubular body 20, an anchor member 22 and at least one suture 24. The implant 10 can be made entirely or partially of a fully bioabsorbable material, such as a bioabsorbable and biocompatible polymer, for example polyglycolic acid, polylactic acid or polydioxanone. Alternatively, at least the tubular body 20 of the implant 10 can be made of a non-bioabsorbable biocompatible material, such as stainless steel, nitinol or polypropylene.

[0034] In this embodiment, there are multiple sutures, such as two or more sutures, which are respectively identified as suture 24-1 and suture 24-2. Each suture 24-1, 24-2 is made of a linear material and can be made of an absorbable material, such as polyglycolic acid, polylactic acid, monoaryl and polydioxanone, or can be made of a non-absorbable material, such as nylon, polyester, polyvinylidene fluoride and polypropylene.

[0035] The tubular body 20 of the implant 10 comprises an inner cavity 20-1, a side wall 20-2, a proximal end portion 20-3 and a distal end portion 20-4 terminating at a distal end portion 20-5. The side wall 20-2 has an outer surface 20-6. In the present embodiment, the distal end portion 20-4 of the tubular body 20 comprises a surface that tapers toward the distal end portion 20-5, such as an annular ramp surface 20-7. The annular ramp surface 20-7 terminates at the inner cavity 20-1 of the tubular body 20 at the distal side. In other words, the annular ramp surface 20-7 terminates at the distal end portion 20-5 of the tubular body 20 at the distal side.

[0036] refer to Figure 3 In some embodiments, a valve 20-8 (eg, a flap or membrane) can be located in the lumen 20-1 of the tubular body 20 to close the lumen 20-1 when the introducer device 12 is removed from the lumen 20-1.

[0037] When being installed on introducer device 12, tubular body 20 is coaxial with elongated sleeve 14 and stylet 16 along longitudinal axis 18.Sidewall 20-2 radially surrounds inner chamber 20-1, and then radially surrounds outer surface 14-2 of elongated sleeve 14.In the present embodiment, the inner chamber 20-1 of tubular body 20 is designed to its size so as to slidably receive outer surface 14-2 of elongated sleeve 14 with tight sliding fit (i.e. sliding friction fit), wherein the sidewall 20-2 of tubular body 20 of implant 10 engages outer surface 14-2 of elongated sleeve 14 with sliding friction.Like this, implant 10 is constructed to separate from elongated sleeve 14 after expansion.If wished, outer sleeve (not shown) can be received on elongated sleeve 14 to engage proximal end 20-3 of tubular body 20, thereby helps to insert implant 1 into patient.

[0038] The anchor member 22 is connected to the distal end portion 20-4 of the tubular body 20, wherein the anchor member 22 can be moved relative to the tubular body 20 from Figure 1-4 The contracted state 26 depicted in FIG. Figure 5 and 6 When the anchor member 22 is in the deployed state 28, at least a portion of the anchor member 22 extends radially outward from the outer surface 20-6 of the side wall 20-2, ie, forms a bulge.

[0039] In the present embodiment, the anchor member 22 comprises a sleeve 30 radially surrounding the side wall 20-2 of the tubular body 20. The sleeve 30 has a first end 30-1, a second end 30-2 and a central portion 30-3 located between the first end 30-1 and the second end 30-2. The sleeve 30 is made of a flexible material (such as a flexible rubber or polymer material) or a mesh material, and the material forming the side wall of the sleeve 30 has a sufficiently thin thickness to promote bulging and / or bunching when the implant 10 moves in the proximal direction and the second end 30-2 of the sleeve 30 engages an obstacle (e.g., the visceral pleura), as described in more detail below.

[0040] The first end 30-1 of the sleeve 30 is attached to the outer surface 20-6 of the side wall 20-2 of the tubular body 20. The second end 30-2 of the sleeve 30 can slide on the outer surface 20-6 of the side wall 20-2 of the tubular body 20, wherein in the retracted state 26, the sleeve 30 has a first longitudinal length 32 (see Figure 4 ), and in the expanded state 28 (see Figure 5 ), the sleeve 30 has a second longitudinal length 34 that is shorter than the first longitudinal length 32. Figure 5 and 6 In the expanded state 28 depicted in FIG. 1 , the central portion 30 - 3 of the sleeve 30 bulges radially away from the side wall 20 - 2 of the tubular body 20 of the implant 10 .

[0041] In the present embodiment, each of the sutures 24-1, 24-2 is connected to the tubular body 20, wherein each of the sutures 24-1, 24-2 extends in the proximal direction from the proximal end 20-3 of the tubular body 20 of the implant 10. In the present embodiment, each of the sutures 24-1, 24-2 can be connected to the proximal end 20-3 of the tubular body 20. The sutures 24-1, 24-2 help the sleeve 30 of the anchor member 22 to move from the contracted state (see Figure 1-4 ) to the expanded state (see Figure 5 and 6 ), i.e., a bulging and / or bunched state, as further described below.

[0042] refer to Figure 6 , which depicts a portion of a patient's chest wall 50 and a lung 52. With the implant 10 disposed on the outer surface 14-2 of the elongated sleeve 14, the introducer device 12 is used to form an access opening 54 to the interior of the lung 52. Specifically, the access opening 54 is formed between adjacent ribs 56-1, 56-2 in the rib cage of the chest wall 50, and extends through the parietal pleura 58, the pleural space 60, and the visceral pleura 62 to form a passage to the interior of the lung. The implant 10 is shown as being disposed in the access opening 54, and the entirety of the sleeve 30 of the anchor member 22 is disposed in the access opening 54, distal to the visceral pleura 62 (i.e., below the visceral pleura 62). Each of the plurality of sutures 24-1, 24-2 extends backward through the access opening 54 to reach the surface of the patient's skin 50-1.

[0043] Once the introducer device 12 enters the lung parenchyma, the implant 10 is moved from the contracted state to the expanded state by pulling the sutures 24-1, 24-2, wherein the implant 10 is pulled back along the access opening 54. As the implant 10 is pulled back, the second end 30-2 (i.e., the rear edge and / or surface) of the sleeve 30 of the anchor member 22 is pulled into contact with the visceral pleura 62, and the central portion 30-3 of the sleeve 30 of the anchor 22 begins to bulge and / or bunch, thereby increasing the contact area between the exterior of the central portion 30-3 of the sleeve 30 and the visceral pleura 62. The sutures 24-1, 24-2 are further pulled, so that the bulging sleeve 30 forces the visceral pleura 62 upward against the parietal pleura 58, thereby generating a clamping force that mechanically seals the pleural layers 58, 62 together in the area around the access opening 54. The sutures 24 - 1 , 24 - 2 are then secured in place on the surface of the patient's skin 50 - 1 , such as by tape, adhesive, or suturing, so as to maintain a seal between the visceral pleura 62 and the parietal pleura 58 in the area surrounding the access opening 54 .

[0044] A lung access procedure, such as a lung biopsy, may be performed by removing the stylet 16 from the elongated cannula 14 and then inserting the lung biopsy device into the lung through the lumen 14-1 of the elongated cannula 14. Alternatively, a lung access procedure may be performed with the entire introducer device 12 removed and the lung biopsy device may be inserted into the lung through the lumen 20-1 of the tubular body 20 of the implant 10.

[0045] Figure 7 An implant 10' is shown as a variation of the implant 10. For convenience, components common to the implants 10 and 10' will share the same reference numerals. The implant 10' differs from the implant 10 in that the anchor member 22 has a channel 23 to separate the side walls of the anchor member 22. The presence of the channel 23 facilitates the movement of the anchor member 22 from the collapsed state 26 (see FIG. Figure 1-4 ) to the expanded (i.e. expanded) state 28 (see Figure 5 and 6 ). Moreover, if desired, the suture 24-1 can be disposed in the channel 23 and attached to the outer surface 20-6 of the tubular body 20, such as at the distal end portion 20-4 of the tubular body 20. It is contemplated that the anchor member 22 can include two or more channels (such as the channel 23), such as two diametrically opposed channels to accommodate the sutures 24-1, 24-2, respectively.

[0046] Implant 10' may be made of a fully bioabsorbable material, such as a bioabsorbable and biocompatible polymer, as described above with reference to implant 10. Alternatively, at least tubular body 20 of implant 10' may be made of a non-bioabsorbable, biocompatible material, as described above with reference to implant 10.

[0047] Figure 8-11 Another implant 110 according to an aspect of the present invention is shown for use in a lung access procedure to help prevent pneumothorax, wherein the implant 110 is shown disposed on an introducer device 12. The introducer device 12 is described above and, for the sake of brevity, will not be discussed in detail here.

[0048] Implant 110 comprises tubular body 120, anchor member 122 and at least one suture 124.Implant 110 can be made of fully bioabsorbable material in whole or in part, such as bioabsorbable and biocompatible polymer, for example polyglycolic acid, polylactic acid or polydioxanone.Alternatively, at least tubular body 120 of implant 110 can be made of non-bioabsorbable biocompatible material, for example stainless steel, nitinol or polypropylene.

[0049] In this embodiment, there are multiple sutures, such as two or more sutures, which are respectively identified as suture 124-1 and suture 124-2. Each suture 124-1, 124-2 is made of a linear material and can be made of an absorbable material, such as polyglycolic acid, polylactic acid, monoaryl and polydioxanone, or can be made of a non-absorbable material, such as nylon, polyester, polyvinylidene fluoride and polypropylene.

[0050] The tubular body 120 of the implant 110 includes an inner cavity 120-1, a side wall 120-2, a proximal end 120-3, and a distal end portion 120-4 terminating at a distal end 120-5. The side wall 120-2 has an outer surface 120-6. In the present embodiment, the distal end portion 120-4 of the tubular body 120 includes a surface that tapers toward the distal end 120-5, such as an annular ramp surface 120-7. The annular ramp surface 120-7 terminates distally at the inner cavity 120-1 of the tubular body 120. In other words, the annular ramp surface 120-7 terminates distally at the distal end 120-5 of the tubular body 120. In the present embodiment, the annular ramp surface 120-7 can be concavely ground to form a concave profile, such as Fig.10 and 11 Best shown in .

[0051] refer to Fig. 9 In some embodiments, a valve 120-8 (eg, a flap or membrane) can be located in the lumen 120-1 of the tubular body 120 to close the lumen 120-1 when the introducer device 12 is removed from the lumen 120-1.

[0052] When mounted on the introducer device 12, the tubular body 120 is coaxial with the elongated cannula 14 and the stylet 16 along the longitudinal axis 18, and the lumen 120-1 of the tubular body 120 is sized to slidably receive and engage the outer surface 14-2 of the elongated cannula 14 with a close sliding fit. The sidewall 120-2 radially surrounds the lumen 120-1, and in turn radially surrounds the outer surface 14-2 of the elongated cannula 14.

[0053] The anchor member 122 is connected to the distal end portion 120-4 of the tubular body 120. In the present embodiment, the anchor member 122 includes a plurality of engagement members 126 at the distal end portion 120-4, the plurality of engagement members 126 being spaced apart from one another and arranged around the sidewall 120-2 of the tubular body 120. In the present embodiment, the plurality of engagement members 126 (shown here as a plurality of triangular prisms) include individual engagement members 126-1, 126-2, 126-3, and 126-4. Fig.10 and 11, each of the plurality of joining members 126 (e.g., triangular prisms) has respective slope surfaces 128-1, 128-2, 128-3, 128-4 and respective proximal surfaces 130-1, 130-2, 130-3, 130-4, wherein each proximal surface 130-1, 130-2, 130-3, 130-4 is substantially perpendicular to the side wall 120-2, and each slope surface 128-1, 128-2, 128-3, 128-4 extends proximally from the side wall 120-2 at an acute angle relative to the side wall 120-2 to connect the respective proximal surfaces 130-1, 130-2, 130-3, 130-4, thereby forming respective vertices 132-1, 132-2, 132-3, 132-4. The term "substantially perpendicular" as used herein refers to perpendicular and a range of ±10 degrees from perpendicular.

[0054] In the present embodiment, engagement members 126-1,126-2,126-3 and 126-4 can be arranged to be opposite along diameter.And, in the present embodiment, each of engagement members 126-1,126-2,126-3 and 126-4 can have roughly right triangle profile, and at least some of various triangle profiles have different sizes.Like this, the radial length of corresponding proximal surface 130-1,130-2,130-3,130-4 can be different between some engagement members.And, notice that engagement members 126-1,126-2,126-3 and 126-4 can be arranged staggered along the length of the sidewall 120-2 of tubular body 120 in the longitudinal direction.

[0055] In the present embodiment, each of the sutures 124-1, 124-2 is connected to the tubular body 120, such as the proximal end 120-3 of the tubular body 120, wherein the sutures 124-1, 124-2 extend in a proximal direction from the proximal end 120-3 of the tubular body 120 of the implant 110. The sutures 124-1, 124-2 facilitate longitudinal movement of the implant 110 in a proximal direction (i.e., toward the user) when pulled.

[0056] refer to Fig.12 , which depicts a portion of a patient's chest wall 50 and lung 52, including an access opening 54 formed between adjacent ribs 56-1, 56-2 in the rib cage of the chest wall 50, and extending through the parietal pleura 58, the pleural space 60, and the visceral pleura 62 to provide access to the interior of the lung. An implant 110 is shown disposed in the access opening 54, with the entirety of the anchor member 122 disposed in the access opening 54, beneath the visceral pleura 62. A plurality of sutures 124-1, 124-2 extend rearwardly through the access opening 54 to the surface of the patient's skin 50-1.

[0057] Once the introducer device 12 enters the lung parenchyma, the implant 110 is moved in the proximal direction by pulling the sutures 124-1, 124-2, wherein the implant 110 is pulled back along the access opening 54. As the implant 110 is pulled back, the proximal surfaces 130-1, 130-2, 130-3, 130-4 of the engagement members 126-1, 126-2, 126-3, and 126-4 of the anchor member 122 (see also Fig.10 and 11 ) are pulled into contact with the visceral pleura 62. As the sutures 124-1, 124-2 are further pulled, at least some of the engagement members 126-1, 126-2, 126-3, and 126-4 of the anchor member 122 force the visceral pleura 62 upward against the parietal pleura 58, thereby generating a clamping force to mechanically seal the pleural layers 58, 62 together in the area around the access opening 54. The sutures 124-1, 124-2 are then secured in place on the surface of the patient's skin 50-1, such as by tape, adhesive, or suturing, so as to maintain a seal between the visceral pleura 62 and the parietal pleura 58 in the area around the access opening 54.

[0058] A lung access procedure, such as a lung biopsy, may be performed by removing the stylet 16 from the elongated cannula 14 and then inserting the lung biopsy device into the lung through the lumen 14-1 of the elongated cannula 14. Alternatively, a lung access procedure may be performed with the entire introducer device 12 removed and the lung biopsy device inserted into the lung through the lumen 120-1 of the tubular body 120 of the implant 110.

[0059] Fig.13 and 14 Shown as Figure 8-12 An implant 110' is a variation of the implant 110. For convenience, components common to the implant 110 and the implant 110' will share the same reference numerals. The implant 110' differs from the implant 110 in that each of the engagement members 126-1, 126-2, 126-3 and 126-4 of the anchor member 122 is configured to retract into the slot when subjected to an external force (e.g., inserted into the lumen 114-1 of the outer sleeve 114).

[0060] exist Fig.13 and 14In the embodiment of the present invention, the side wall 120-2 of the tubular body 120 includes a plurality of longitudinal slots 134-1, 134-2, 134-3 and 134-4, which extend radially from the outer surface 120-6 to the inner cavity 120-1 of the tubular body 120. Each of the plurality of engagement members 126-1, 126-2, 126-3 and 126-4 includes a distal hinge 136-1, 136-2, 136-3, 136-4, for example, made of a memory material, which connects the corresponding engagement member to the tubular body 120. Each longitudinal slot of the plurality of longitudinal slots 134-1, 134-2, 134-3 and 134-4 is configured to radially receive a corresponding engagement member of the plurality of engagement members 126-1, 126-2, 126-3 and 126-4 of the anchor member 122.

[0061] When implant 110' is inserted into lumen 114-1 of outer sleeve 114, each of plurality of engagement members 126-1, 126-2, 126-3 and 126-4 pivots at its respective distal hinge 136-1, 136-2, 136-3, 136-4 and retracts into respective longitudinal slots of plurality of longitudinal slots 134-1, 134-2, 134-3 and 134-4. When the implant 110' is removed from the inner cavity 114-1 of the outer sleeve 114 (for example, by being pushed by a push rod), each of the multiple engaging members 126-1, 126-2, 126-3 and 126-4 pivots at its corresponding distal hinge 136-1, 136-2, 136-3, 136-4 to return to an extended position, i.e., extending radially outward from the corresponding longitudinal slots of the multiple longitudinal slots 134-1, 134-2, 134-3 and 134-4.

[0062] refer to Figure 15-17 , which shows an implant 210 according to another embodiment of the present invention.

[0063] Implant 210 includes a tubular body 212, an anchor member 214, and at least one suture 216. Implant 210 can be made of a fully bioabsorbable material, such as a bioabsorbable and biocompatible polymer, such as polyglycolic acid, polylactic acid, or polydioxanone. Alternatively, implant 210 can be made entirely or partially of a non-bioabsorbable biocompatible material, such as stainless steel, nitinol, or polypropylene.

[0064] In this embodiment, there are multiple sutures, such as two or more sutures, which are respectively identified as suture 216-1 and suture 216-2. Sutures 216-1, 216-2 can be connected to the first end 218-1 of the mesh sleeve 218. Each suture 216-1, 216-2 is made of a linear material and can be made of an absorbable material, such as polyglycolic acid, polylactic acid, monoaryl and polydioxanone, or can be made of a non-absorbable material, such as nylon, polyester, polyvinylidene fluoride and polypropylene.

[0065] In this embodiment, the anchor member 214 includes a mesh sleeve 218 made of a flexible material such as a flexible rubber or polymer material. The mesh sleeve 218 has a first end 218-1, a second end 218-2, and a central portion 218-3 located between the first end 218-1 and the second end 218-2.

[0066] The mesh sleeve 218 can be relative to the tubular body 212 from Fig.15 The contracted state 220 depicted in FIG. Fig.16 and 17 When the mesh sleeve 218 of the anchor member 214 is in the expanded state 222, at least a portion of the anchor member 214 extends radially outward, that is, forms a bulging state. More specifically, in Fig.16 and 17 In the expanded state 222 depicted in FIG. 2 , the central portion 218 - 3 of the mesh sleeve 218 bulges radially outward from the tubular body 212 of the implant 210 .

[0067] The sutures 216-1, 216-2 extend in a proximal direction from the tubular body 212 of the implant 210. When the sutures 216-1, 216-2 are pulled, the sutures 216-1, 216-2 help the mesh sleeve 218 of the anchor member 214 to move from a contracted state 222 (see FIG. Fig.15 ) is transformed into the unfolded state, i.e. the bulging state 222 (see Fig.16 and 17 ).

[0068] To facilitate deployment in a patient, implant 210 may be disposed within the lumen of an introducer cannula, such as a Fig.13 The outer sleeve 114 has an inner cavity 114-1 as depicted in the figure and can be pushed out of the inner cavity by using a push rod.

[0069] The following items are also relevant to the present invention:

[0070] In one form, the present invention is directed to an implant for use in a lung access procedure to help prevent pneumothorax. The implant may include a tubular body having an inner cavity, a proximal end, and a distal end portion terminating at a distal end, and wherein the tubular body has a longitudinal axis and has a sidewall radially surrounding the inner cavity, the sidewall having an outer surface. An anchor member may be connected to the tubular body, wherein the anchor member may be movable from a contracted state to an expanded state relative to the tubular body. At least one suture may be connected to the tubular body, wherein the at least one suture extends in a proximal direction from the proximal end of the tubular body.

[0071] In any of the various embodiments, at least a portion of the anchor member may extend radially outward from the outer surface of the sidewall when the anchor member is in the deployed state.

[0072] In some embodiments, the anchor member can include a plurality of engagement members spaced apart from one another and disposed about the sidewall of the tubular body.

[0073] In some embodiments, each of the plurality of engagement members may have a ramp surface and a proximal surface, wherein the proximal surface may be perpendicular to the sidewall and the ramp surface may extend proximally from the sidewall at an acute angle relative to the sidewall to connect the proximal surface to form an apex.

[0074] In some embodiments, the sidewall of the tubular body can include a plurality of longitudinal slots extending radially from the outer surface to the inner cavity, and wherein each longitudinal slot of the plurality of longitudinal slots can be configured to receive a corresponding engagement member of the plurality of engagement members.

[0075] In some embodiments, the anchor member may include a sleeve radially surrounding the side wall, wherein the sleeve may be made of a flexible material, the sleeve having a first end and a second end, wherein the first end may be attached to an outer surface of the side wall and the second end may be slidable on the outer surface of the side wall, wherein in a retracted state, the sleeve has a first longitudinal length, and in an expanded state, the sleeve has a second longitudinal length that is shorter than the first longitudinal length.

[0076] In the embodiment described immediately above, in the expanded state, the central portion of the sleeve may bulge radially away from the side wall of the tubular body.

[0077] In any of the various embodiments, the distal end portion of the tubular body can include an annular ramp surface that terminates distally at the lumen at the distal end of the tubular body.

[0078] In any of the various embodiments, the distal end portion of the tubular body can include a ramped surface that terminates distally at the distal end of the tubular body.

[0079] In any of the various embodiments, each of the tubular body and the anchor member can be made of a bioabsorbable material.

[0080] In another form, the present invention relates to an introducer system for a lung access procedure to help prevent pneumothorax. The system may include an elongated sleeve having an outer surface and a longitudinal axis. An implant may be coaxial with the elongated sleeve. The implant may include a tubular body having an inner cavity, a proximal portion, and a distal portion terminating at a distal portion, and wherein the tubular body has a sidewall radially surrounding the inner cavity, the sidewall having an outer surface, and wherein a portion of the elongated sleeve may be able to slide in the inner cavity of the tubular body. An anchor member may be connected to the distal portion of the tubular body, wherein the anchor member may be able to move from a contracted state to an expanded state relative to the tubular body. At least one suture, and in some embodiments multiple sutures, may be connected to the tubular body, wherein the suture extends in a proximal direction from the proximal portion of the tubular body.

[0081] In any of the various embodiments, at least a portion of the anchor member may extend radially outward from the outer surface of the sidewall when the anchor member is in the deployed state.

[0082] In some embodiments, the anchor member can include a plurality of engagement members spaced apart from one another and disposed about the sidewall of the tubular body.

[0083] In some embodiments, each of the plurality of engagement members may have a ramp surface and a proximal surface, wherein the proximal surface may be perpendicular to the sidewall and the ramp surface may extend proximally from the sidewall at an acute angle relative to the sidewall to connect the proximal surface to form an apex.

[0084] In some embodiments, the sidewall of the tubular body can include a plurality of longitudinal slots extending radially from the outer surface to the inner cavity, and wherein each longitudinal slot of the plurality of longitudinal slots can be configured to receive a corresponding engagement member of the plurality of engagement members.

[0085] In some embodiments, the anchor member may include a sleeve radially surrounding the side wall, wherein the sleeve may be made of a flexible material, the sleeve having a first end and a second end, wherein the first end may be attached to an outer surface of the side wall and the second end may be slidable on the outer surface of the side wall, wherein in a retracted state, the sleeve has a first longitudinal length, and in an expanded state, the sleeve has a second longitudinal length that is shorter than the first longitudinal length.

[0086] In the embodiment described immediately above, in the expanded state, the central portion of the sleeve may bulge radially away from the side wall of the tubular body.

[0087] In any of the various embodiments, the distal end portion of the tubular body can include an annular ramp surface that terminates distally at the lumen at the distal end of the tubular body.

[0088] In any of the various embodiments, the distal end portion of the tubular body can include a planar ramp surface that terminates distally at the distal end of the tubular body.

[0089] In any of the various embodiments, the sidewall of the tubular body of the implant can be frictionally engaged with the outer surface of the elongated sleeve, wherein the implant can be configured to be separated from the elongated sleeve.

[0090] Although the present invention has been described with reference to a plurality of embodiments, the present invention can also be modified within the spirit and scope of the present disclosure. Therefore, the present application is intended to cover any variation, use or change of the present invention using its general principle. In addition, the present application should be covered within the known or common practice range in the field described in the present invention and fall within the limits of the appended claims. Various deviation forms based on the present disclosure.

Claims

1. An implant to be inserted into the chest wall of a patient during a lung access procedure to help prevent pneumothorax, the implant comprising: a tubular body having an inner lumen, a proximal end, and a distal end portion terminating in a distal end and positioned in an access opening through a chest wall to an interior of a lung, and wherein the tubular body has a longitudinal axis and has a sidewall radially surrounding the inner lumen, the sidewall having an outer surface; an anchor member connected to the tubular body, wherein the anchor member is movable relative to the tubular body from a contracted state to an expanded state, the anchor member comprising a plurality of engagement members located distal to a pleural layer of the chest wall, and wherein each of the plurality of engagement members has a ramp surface and a proximal surface capable of contacting the pleural layer; and at least one wire connected to the tubular body, wherein the at least one wire is configured to extend from a proximal end of the tubular body in a proximal direction and be secured to a surface of the patient's skin to maintain a seal between the parietal pleura and the visceral pleura of the pleural layer; wherein the sidewall of the tubular body includes a plurality of longitudinal slots extending radially from the outer surface to the inner cavity, wherein each longitudinal slot of the plurality of longitudinal slots is configured to receive a corresponding engagement member of the plurality of engagement members; wherein each of the plurality of engaging members comprises a distal hinge connecting the corresponding engaging member to the tubular body; wherein the implant further comprises an outer sleeve, and wherein the tubular body of the implant can be inserted into and removed from the inner cavity of the outer sleeve.

2. The implant according to claim 1, wherein At least a portion of the anchor member extends radially outward from an outer surface of the sidewall when the anchor member is in the deployed state.

3. The implant according to claim 1, wherein The plurality of engagement members are spaced apart from one another and are arranged around the sidewall of the tubular body.

4. The implant according to claim 1, wherein The proximal surface is perpendicular to the sidewall and the ramp surface extends proximally from the sidewall at an acute angle relative to the sidewall to connect the proximal surfaces to form an apex.

5. The implant according to claim 3 or 4, wherein: The distal hinge is made of memory material; and wherein, when the tubular body of the implant is inserted into the inner cavity of the outer sleeve, each of the multiple engaging members pivots at its corresponding distal hinge and retracts into the corresponding longitudinal slot, and wherein, when the tubular body of the implant is removed from the inner cavity of the outer sleeve, each of the multiple engaging members pivots at its corresponding distal hinge to return to the extended position, i.e., extending radially outward from the corresponding longitudinal slot.

6. An implant to be inserted into the chest wall of a patient during a lung access procedure to help prevent pneumothorax, the implant comprising: a tubular body having an inner lumen, a proximal end, and a distal end portion terminating in a distal end and positioned in an access opening through a chest wall to an interior of a lung, and wherein the tubular body has a longitudinal axis and has a sidewall radially surrounding the inner lumen, the sidewall having an outer surface; an anchor member connected to the tubular body, wherein the anchor member is movable relative to the tubular body from a contracted state to an expanded state, wherein the anchor member comprises a sleeve located distal to a pleural layer of the chest wall and radially surrounding the side wall, wherein the sleeve is made of a flexible material, the sleeve having a first end and a second end, wherein the first end is attached to an outer surface of the side wall and the second end is slidable on the outer surface of the side wall, wherein in the contracted state the sleeve has a first longitudinal length, and in the expanded state the sleeve has a second longitudinal length, the second longitudinal length being shorter than the first longitudinal length; and at least one wire connected to the tubular body, wherein the at least one wire is configured to extend from a proximal end of the tubular body in a proximal direction and be secured to a surface of the patient's skin to maintain a seal between the parietal pleura and the visceral pleura of the pleural layer; and wherein the anchor member has a channel to separate side walls of the anchor member, and wherein the at least one wire is disposed in the channel.

7. The implant according to claim 6, wherein In the expanded state, a central portion of the sleeve bulges radially away from a side wall of the tubular body.

8. The implant according to claim 1 or 6, wherein: The distal end portion of the tubular body includes an annular ramp surface that terminates distally into the lumen at the distal end of the tubular body.

9. The implant according to claim 1 or 6, wherein: The distal end portion of the tubular body includes a ramp surface that terminates distally at the distal end of the tubular body.

10. The implant according to claim 1 or 6, wherein: Each of the tubular body and the anchor member is made of a bioabsorbable material.

11. An introducer system to be inserted into the chest wall of a patient to help prevent pneumothorax during a lung access procedure, the introducer system comprising: an elongated sleeve having an outer surface and a longitudinal axis; as well as an implant coaxial with the elongated sleeve, the implant comprising: a tubular body having an inner lumen, a proximal end, and a distal end portion terminating in a distal end and positioned in an access opening through a chest wall to an interior of a lung, and wherein the tubular body has a sidewall radially surrounding the inner lumen, the sidewall having an outer surface, and wherein a portion of the elongated sleeve is slidable within the inner lumen of the tubular body; an anchor member connected to a distal end portion of the tubular body, wherein the anchor member is movable from a collapsed state to an expanded state relative to the tubular body and is located distal to a pleural layer of the chest wall; and at least one wire connected to the tubular body, wherein the at least one wire is configured to extend from a proximal end of the tubular body in a proximal direction and be secured to a surface of the patient's skin to maintain a seal between the parietal pleura and the visceral pleura of the pleural layer; The anchor member includes a plurality of engagement members spaced apart from one another and arranged around a sidewall of the tubular body and configured to contact a pleural layer; wherein the sidewall of the tubular body includes a plurality of longitudinal slots extending radially from the outer surface to the inner cavity, wherein each longitudinal slot of the plurality of longitudinal slots is configured to receive a corresponding engagement member of the plurality of engagement members; wherein each of the plurality of engagement members comprises a distal hinge connecting the corresponding engagement member to the tubular body; wherein the implant further comprises an outer sleeve, and wherein the implant is insertable into and removable from the inner cavity of the outer sleeve.

12. The introducer system of claim 11, wherein: At least a portion of the anchor member extends radially outward from an outer surface of the sidewall when the anchor member is in the deployed state.

13. The introducer system of claim 11, wherein: The distal hinge is made of memory material.

14. The introducer system of claim 13, wherein: Each of the plurality of engagement members has a ramp surface and a proximal surface, wherein the proximal surface is perpendicular to the sidewall and the ramp surface extends proximally from the sidewall at an acute angle relative to the sidewall to connect the proximal surface to form an apex.

15. The introducer system of claim 11, wherein: When the implant is inserted into the inner cavity of the outer sleeve, each of the multiple engaging members pivots at its corresponding distal hinge and retracts into the corresponding longitudinal slot, and wherein, when the implant is removed from the inner cavity of the outer sleeve, each of the multiple engaging members pivots at its corresponding distal hinge to return to an extended position, i.e., extending radially outward from the corresponding longitudinal slot.

16. The introducer system according to any one of claims 11 to 15, wherein: The distal end portion of the tubular body includes an annular ramp surface that terminates distally into the lumen at the distal end of the tubular body.

17. The introducer system according to any one of claims 11 to 15, wherein: The distal end portion of the tubular body includes a planar ramp surface that terminates distally at the distal end of the tubular body.

18. The introducer system of any one of claims 11 to 15, wherein: The sidewall of the tubular body of the implant is frictionally engaged with the outer surface of the elongated sleeve, and the implant is configured to be separated from the elongated sleeve.

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