Source: https://patents.google.com/patent/CA2454154C
Timestamp: 2018-03-23 05:37:23
Document Index: 618557382

Matched Legal Cases: ['art 22', 'art 24', 'art 22', 'art 24', 'art 22', 'arts 22']

CA2454154C - Radially dilatable percutaneous access apparatus with introducer seal in handle - Google Patents
CA2454154C
CA2454154C CA 2454154 CA2454154A CA2454154C CA 2454154 C CA2454154 C CA 2454154C CA 2454154 CA2454154 CA 2454154 CA 2454154 A CA2454154 A CA 2454154A CA 2454154 C CA2454154 C CA 2454154C
CA2454154A1 (en )
, RADIALLY DILATABLE PERCUTANEOUS ACCESS APPARATUS
WITH INTRODUCER SEAL IN HANDLE
1. Technical Field The present disclosure relates generally to apparatus and methods for providing percutaneous access to an internal. operative site during a surgical procedure and, more particularly, to apparatus and methods for creating a fluid-tight seal around an outer surface of a surgical instrument inserted therethrough, for reducing the amount of insertion force required to insert a surgical instrument therein and for delivering a medicament to the target delivery site.
2. Backuound of Related Art Minimally invasive surgical procedures are performed throughout the body and generally rely on obtaining percutaneous access to an internal surgical site using small diameter tubes (typically 5 to 12 mm), usually referred to as trocars, which penetrate through the skin of the patient and open adjacent the desired surgical site. A
viewing scope is introduced through one such trocar, and the surgeon operates using instruments introduced through other appropriately positioned trocars while viewing the operative site on a video monitor connected to the viewing scope. The surgeon is thus able to perform a wide variety of surgical procedures requiring only a few 5 to 12 mm punctures through the patient's skin, tissue, etc. adjacent the surgical site.
Pneumoperitoneum is established through the use of a special insufflation needle, called a Veress needle which has a spring-loaded obturator that advances over the sharp tip of the needle as soon as the needle enters the abdominal cavity.
This needle is inserted through the fascia and through the peritoneum. Generally, the surgeon relies on tactile senses to determine the proper placement of the needle by recognizing when the needle is inserted through the fascia and then through the peritoneum. After establishing pneumoperitoneum, the next step in laparoscopic surgery involves the insertion of a trocar, obturator or trocar/obturator assembly into the abdominal cavity.
In order to reduce the amount of insufflation gas which escapes from the abdominal cavity, a radially expandable access system has been developed to provide improved sealing about the periphery of the trocar. A system for performing such a function is commercially available from United States Surgical, a division of Tyco Healthcare, Ltd. under the trademark VERSAPORTTM. Certain aspects of the expandable access system are described in commonly assigned U.S. Pat. Nos.:
5,431,676; 5,814,058; 5,827,319; 6,080,174; 6,245,052 and 6,325,812.
As disclosed therein, the expandable access system includes a sleeve having a sleeve body, typically made up of a radially expandable braid covered by an elastomeric layer. The braid initially has an inner diameter of about 2 mm and an outer diameter of about 3.5mm. In use, passage of a surgical instrument (i.e., trocar, cannula, obturator, etc.) through the expandable access system causes radial expansion of the sleeve, typically to a final diameter of 5mm, 10mm or 12mm. However, the sleeve can be expanded to any necessary diameter in order to accommodate the particular surgical instrument. The expandable access system further includes a handle affixed to a proximal end of the sleeve, the handle including a passage formed therein for the introduction of surgical instruments, through the handle, into the sleeve body.
A method of use of the expandable sealing apparatus includes inserting a pneumoperitoneum needle through the radially expandable sleeve body of the expandable access system to thereby form a needle/sleeve assembly. The needle/sleeve assembly is then introduced through the patient's abdomen by engaging the sharpened distal end of the pneumoperitoneum needle, protruding from the distal end of the sleeve body, against the body tissue of the body cavity and advancing the needle/sleeve assembly into the body cavity until the needle/sleeve assembly extends across the layers of the body tissue thereby forming an incision in the body tissue. The pneumoperitoneum needle is then removed from the body of the sleeve. A trocar, having a diameter smaller than the opening in the handle and larger than the lumen of the sleeve, is then introduced through the opening in the handle and into the abdomen of the patient. As a result, due to radial expansion of the sleeve by the trocar, the incision is subsequently also radially expanded.
Trocars used in laparoscopic procedures include a valve at a proximal end thereof in order to permit passage of a viewing scope or other surgical instrument therethrough while simultaneously inhibiting escape of insufflation gas from the abdominal cavity.
A surgical access system for forming and enlarging a percutaneous penetration is disclosed. The surgical access system includes a radially expandable dilation assembly .. 3 having a radially expandable sleeve body defining a lumen having a first cross-sectional area and a handle portion coupled to a proximal end of the sleeve body. The handle portion defines an aperture formed therein. The access system further includes an expansion assembly including an expansion member having an axial lumen with a second cross-sectional area, wherein the expansion member is configured and dimensioned to be selectively receivable within the aperture formed in the handle portion and the lumen of the sleeve body. The access system also includes a polymeric layer which encases the sleeve body.
Preferably, the handle portion of the radially expandable dilation assembly includes a seal extending across the aperture and disposed at a location proximal of the valve stem.
The seal forms a fluid-tight seal around the expansion member upon insertion of the expansion member into the handle portion of the dilation assembly.
In one embodiment, the radially projecting element includes a plurality of longitudinal ribs extending substantially the length of the expansion member.
It is contemplated that the plurality of longitudinal ribs can have a triangular, hexagonal, polygonal or hemi-spherical cross-sectional profile. In another embodiment, the radially projecting element can include a plurality of bumps projecting radially outward from an outer surface of the expansion member. It is contemplated that the plurality of bumps can have a hemi-spherical, conical, pyramidal or polygonal cross-sectional profile. In yet another embodiment, the radially projecting element is a helical thread, wherein the helical thread preferably extends substantially along the length of expansion member.
In still a further embodiment, the handle portion of the radially expandable dilation assembly includes an introducer seal disposed across the aperture formed in the handle portion and defines an opening formed therein. The introducer seal forms a fluid-tight seal around a proximal portion of the expansion member when the expansion member is inserted through the handle portion and into the sleeve body of the dilation assembly.
Preferably, the introducer seal is made of a resilient polymeric material and, more preferably, polyisoprene.
FIG. 10 is a detailed view, partly in cross-section taken at region 10--10 of the surgical access and medicament delivery system of FIG. 9;
FIG. 31 is a cross-sectional side elevational view, taken along the longitudinal axis, of a radial expandable dilation assembly configured and adapted to be co-operable with the elongated expansion assembly of FIG. 30; and FIGS. 32-35 illustrate use of the access and medicament delivery system using the expansion assembly and expandable dilation assembly of FIGS. 30 and 31.
Referring now to FIG. 1, radially expandable dilation assembly 10 includes a conformable sleeve body 12, defining a lumen therethrough, and a handle assembly 20 operatively coupled to a proximal end thereof. It is contemplated that sleeve body 12 includes a radially expandable braid covered by an elastomeric sleeve 134 (See FIGS. 9-22), made of, for example, polyurethane. Sleeve body 12 has an initial inner diameter of about 2mm and an initial outer diameter of about 3.5mm. In"use, passage of a surgical instrurnent, in the form of a fixed radius expansion assembly, i.e., an obturator, into the lumen of sleeve body 12 causes radial expansion of sleeve body 12 from its initial diameter to a final diameter corresponding tb the size of the surgical instrument received therein, typically about 5mm, 10mm or 12mm. Radially expandable sleeve assembly 10 may be constructed in accordance with the details set forth in U.S. Pat. No.
5,431,676.
Referring now to FIGS. 2-4, handle assembly 20 includes a handle portion 14, a lower housing part 22, and an upper housing part 24 which is preferably snap fit to lower housing part 22. Handle assembly 20 defines an aperture or passage 16 extending through upper housing part 24, handle portion 14 and lower housing part 22. Passage 16 provides access to the lumen of sleeve body 12. Handle assembly 20 further includes an introducer sea126 clamped between lower and upper housing parts 22, 24 and extending across passage 16. Introducer sea126 is provided with an opening 28 formed therein for providing access for an expansion assembly into passage 16 and subsequently into the lumen of sleeve body 12.
Preferably, introducer seal 26 includes an integrally formed raised rim portion 30 extending around a periphery of opening 28. Raised rim portion 30 provides opening 28 of introducer sea126 with increased resiliency. As seen in FIGS. 3 and 4, rim portion 30 is provided on the proximal surface of introducer seal 26, however, it is envisioned that rim portion 30 can be provided on the distal surface of introducer seal 26 or on both the proximal and the distal surfaces of introducer sea126. Turning now to FIG. 5, it is seen that introducer seal 26 may be provided with a toroidal rim 32 formed along the inner periphery of opening 28.
Preferably, introducer seal 26 is made from a resilient polymeric material, most preferably polyisoprene, or a combination of materials. As best seen in FIG.
6, introducer seal 26 may be provided with a layer of fabric 40 disposed on either the proximal surface, the distal surface or preferably on both the proximal and distal surfaces thereof. Fabric 40 may be any suitable fabric, for example, a spandex-like material (i.e., spandex is typically defined by having long chain synthetic polymers comprised of at least 85% by weight of segmented polyurethane) containing about 20% LYCRA and about 80% NYLON
available from the Milliken & Company. As seen in FIG. 7, an alternative embodiment of introducer seal 26 is shown. In the embodiment of FIG. 7, introducer sea126 includes a fabric layer 40 enveloped between upper and lower polyisoprene layers 26a and 26b, respectively.
By way of example, one method of forming introducer seal 26, having a layer of fabric 40 disposed on a surface thereof, involves compressing a quantity of polyisoprene into a flat sheet. A single layer of fabric 40 is placed on one side of the flat sheet of polyisoprene and then compressed into the uncured flat sheet by compressing in a calender for example. If it is desired to have fabric 40 disposed on both sides of introducer sea126, this process is also accomplished on the other side of the polyisoprene sheet.
The fabric polyisoprene composite is then die cut into circular slugs having an outer diameter and an inner diameter which defines opening 28. The slugs are then placed in a hot compression mold to cure the polyisoprene. This step also serves to extrude the outer portions of introducer seal 26 which extend outwardly from an inner section of introducer seal 26.
During the above-described process the bleed through of the polyisoprene material into and/or through the layers of fabric 40 is regulated by the density of the fabric selected.
A greater degree of bleed-through of polyisoprene provides greater resistance to fraying of fabric 40 upon repeated insertion of instruments through introducer seal 26.
However, too much bleed-through of the polyisoprene through fabric 40 will increase friction forces upon instruments being inserted through introducer seal 26.
In order to reduce friction between surgical instruments and introducer sea126, as surgical instruments are inserted through handle assembly 20, a substance such as a lubricant may be applied to introducer seal 26 or, in the alternative, to the surgical instrument. A particularly effective lubricant is a hydrocyclosiloxane membrane prepared by a plasma polymerization process. Such a lubricant is available from Innerdyne, Inc. of Salt Lake City, Utah, U.S.A., and is disclosed in U.S. Patent No. 5,463,010 which issued to Hu et al. on October 31, 1995.
Insertion of a surgical instrument, such as a trocar "T", through opening 28 of introducer seal 26 and distally, in a direction of arrow "F", into the lumen of sleeve body 12, is shown in FIG. 8. With radially expandable dilation sleeve assembly 10 inserted through a percutaneous incision, as trocar "T" is inserted through opening 28 of introducer ., _ _ sea126, trocar "T" stretches opening 28 radially outward thereby creating a fluid-tight seal between the outer surface of trocar "T" and introducer sea126. As trocar "T"
is further distally advanced through handle assembly 20 of radially expandable dilation assembly 10, trocar "T" enters the lumen of sleeve body 12 thereby expanding sleeve body 12 radially outward as well as radially expanding an incision made in a body wall and effectively sealing the perimeter of the incision against the escape of insufflation gas.
In other words, insufflation gas is prevented from escaping from between the incision in the body wall and sleeve body 12 due to the radial expansion of sleeve body 12 against the incision as well as prevented from escaping from within radially expandable sleeve body 12 due to the fluid-tight seal created about the outer surface of trocar "T" by rim portion 30 of introducer seal 26.
The access and medicament delivery system includes a number of individual components that can be assembled into different size configurations. The assembled components can also be disassembled after use, and the components selectively sterilized or replaced prior to reassembling the access system for further use with a different patient.
The different components and component assemblies and subassemblies will be described in greater detail below.
Sterilization of the components of the access and medicament delivery system can be accomplished by any suitable conventional sterilization technique, including heat (e.g., steam and autoclaving), chemical treatment (e.g., ethylene oxide exposure, radiation, etc.) and the like. After use, reusable components will be washed to remove blood and other contaminating substances and then sterilized, preferably by exposure to steam.
Disposable components will usually be radiation sterilized in their packages prior to distribution.
Thus, disposable components are ready to use out of the package.
Elongate dilation assembly 102 includes an elongate dilation member 108 (similar in structure to radially expandable dilation assembly 10 described above) having a tubular braid 120 defining an axial lumen therethrough and a handle 122 connected to a proximal end of braid 120. Handle 122 has a passage 126 provided therein (see FIG. 9A) to permit passage of expansion assemblies 104 into the axial lumen of tubular braid 120.
Tubular braid 120 is encased by a removable sheath 130 having a handle 132 at a proximal end thereof. Sheath 130 extends the entire length of tubular braid 120 and terminates at its distal end, generally at the location of a ferrule 124, as best illustrated in FIG. 10.
In a preferred embodiment, tubular braid 120 is laminated or covered with a coating, layer or sleeve 134 of elastic or plastically deformable material, such as silicone rubber, latex, polyethylene C-flex, or the like. Tubular braid 120 is percutaneously introduced while in its narrow-diameter configuration, and thereafter radially expanded using elongate expansion assemblies 104. Tubular braid 120 is preferably formed as a mesh of individual non-elastic filaments (e.g., composed of polyamide fiber (Kevlar , DuPont), stainless steel, or the like) arranged such that radial expansion of braid 120 causes axial shortening of braid 120. Upon expansion, the braid filaments displace radially outwardly, thereby causing sleeve 134 to become pressed into the surrounding tissue and thereby anchoring dilation member 108 in place within the patient's tissue.
As best depicted in FIG. 9A, in conjunction with FIG. 9, sleeve 134 is provided with a plurality of radially oriented delivery holes 136 formed near a distal end thereof, as designated by region "A" in FIG. 9. In a preferred embodiment, delivery holes 136 are located along a single side of sleeve 134. Handle 122 of elongate dilation member 108 can be provided with a marking (not shown) on its outer surface, which marking is in linear alignment with delivery holes 136. In this manner, when tubular braid 120 is within the body cavity, the surgeon will be able to ascertain the orientation and direction of delivery holes 136 by observing the orientation and direction of the marking formed on handle 122.
While delivery holes 136 have been disclosed above as being formed along a single side of sleeve 134, it is envisioned that diametrically opposed rows, multiple rows of radially oriented delivery holes or a plurality of randomly located delivery holes can be formed near a distal end of and around the periphery of sleeve 134. In another preferred embodiment, it is envisioned that delivery holes 136 can vary in diameter from a proximal portion of sleeve 134 toward a distal portion of sleeve 134.
In accordance with the present disclosure, as seen in FIG. 9A, elongate dilation member 108 is provided with a valve stem 138 operatively coupled to handle 122. Valve stem 138 is provided with a lumen 139 extending therethrough and opening into passage 126 of handle 122. As will be described in greater detail below, in use, valve stem 138 is coupled to a source of medicament (not shown) for the injection of a medicament "M", into passage 126 of handle 122, and ultimately on through tubular braid 120.
It is contemplated that handle 122 of elongate dilation member 108 preferably includes an introducer seal 131 disposed across the proximal most opening of handle 122.
Preferably, introducer seal 131 includes all of the features of introducer seal 26 described above with regard to FIGS. 1-8. Further, as seen in FIG. 9A, the distal portion of sleeve 134 extends beyond the distal most portion of tubular braid 120 and defines a distal sealing cuff 135. In this manner, when elongate expansion assembly 104 is introduced into dilation member 108, introducer seal 131 acts to create a fluid-tight seal about a proximal portion thereof while sealing cuff 135 acts to create a fluid-tight seal about a distal portion thereof.
The access and medicament delivery system 100 further includes a sheath 130.
Sheath 130 is preferably composed of a lubricous material, such as a thin-walled flexible plastic, such as polyethylene, tetrafluoroethylene, fluorinated ethylenepropylene, and the like. Sheath 130 protects tubular braid 120 during initial insertion of dilation member 108, but is removed from about braid 120 after dilation member 108 is in place.
Preferably, sheath 130 will be weakened along an axial line to facilitate a splitting of sheath 130 at some point during the procedure, as will be described below.
Needle assembly 140 is preferably in the form of an insufflation needle having a protective element at its distal tip 142. As illustrated, the protective element is an obturator 148 having a blunt distal end 150 which is reciprocably received in the axial lumen of needle assembly 140. Obturator 148 is spring-loaded so that blunt end extends distally from sharpened distal tip 142 of needle assembly 140 in its shelf or "at rest" configuration. As distal tip 142 of needle assembly 140 is pressed firmly against the patient's skin or other tissue, however, blunt end 150 will be retracted back into needle assembly 140 so that sharpened tip 142 can penetrate. Usually, obturator 148 will be hollow and include a port 152 at its distal end. By providing a valve assembly 154 (see FIGS. 9 and 11) at its proximal end, the combination of needle assembly 140 and obturator 148 can be used to introduce or withdraw insufflation fluids, particularly being useful for performing the initial stages of insufflation. Insufflation needles which can be modified for use in the present disclosure are available from United States Surgical Corporation, Norwalk, Conn. (available under the tradename Auto Suture Surgineedle ).
The axial lumen of fixed-radius tubular element 160 has a cross-sectional area which is greater than that of tubular braid 120 while tubular braid 120 is in its non-radially expanded configuration. Accordingly, by introducing expansion assembly 104 through the lumen of dilation member 108 and causing braid 120 to radially expand, an enlarged , , . .. . _ access channel will be provided by the lumen of fixed-radius tubular element 160. To facilitate introduction of elongate expansion assembly 104 through the axial lumen of dilation member 108, an internal obturator or rod 174 having a handle 176 at its proximal end and a tapered conical surface 178 at its distal end is preferably provided and positioned in the lumen of tubular element 160. Tapered conical surface 178 extends distally from tubular element 160 and acts to radially expand tubular braid 120 as expansion assembly 104 is advanced. Obturator 174 can then be removed from tubular element 160 to leave the access lumen of tubular element 160 unobstructed.
Referring now to FIGS. 13 and 14, insertion of elongate expansion assembly 104 through elongate dilation assembly 102 will be described in greater detail. It shall be appreciated by those skilled in the art that, prior to introducing expansion assembly 104, needle assembly 140 will have been removed from the axial lumen of dilation member 108 of dilation assembly 102. The tapered distal end 178 of obturator 174, positioned within elongate expansion assembly 104, is introduced through passage 126 in handle 122 and thus enters the axial lumen of dilation member 108. Sheath 130 will optionally have already been split by withdrawal of needle assembly 140 and passage of ferrule through sheath 130. Alternatively, if needle assembly 140 does not cause sheath 130 to split, introduction of expansion assembly 104 through dilation assembly 102 will cause sheath 130 to split as a result of radial expansion of tubular braid 120 and sleeve 134.
Eventually, introduction of expansion assembly 104 will result in the full expansion of braid 120, as illustrated in FIG. 14.
Referring now to FIGS. 15-22, use of the exemplary access and medicament delivery system of the present disclosure, for performing a percutaneous penetration and for delivering a medicament to a target surgical site will be described.
Elongate dilation assembly 102 is initially positioned at a location on the patient's skin "S"
where it is desired to form the penetration. Dilation assembly 102 is then penetrated through skin "S"
by advancing sharpened distal tip 142 of needle assembly 140 (see FIG. 9) through skin "S" as illustrated in FIG. 15. In the case of laparoscopic procedures, as soon as sharpened tip 142 of needle assembly 140 penetrates through skin "S" and into the surgical site, blunt end 150 of obturator 148 automatically extends to protect the patient's internal organs from accidental injury. At this point, the lumen of needle assembly 140 may be used for insufflation if desired.
After dilation assembly 102 has been advanced to its desired location, needle assembly 140 will be withdrawn using handle 144, leaving sheath 130 (which may have been split by withdrawal of needle assembly 140 and attached ferrule 124) and tubular braid 120 with handle 122 at its proximal end therein, as illustrated in FIG.
17. Elongate expansion assembly 104 with mounted obturator 174 is next introduced through passage 126 of handle 122, thus expanding both tubular braid 120 and sleeve 134 and splitting sheath 130 (if not already split from above), as illustrated in FIG. 18. The presence of sleeve 134 and braid 120 facilitates radial expansion of the penetration which has been formed through skin "S". After expansion assembly 104 has been fully inserted through dilation assembly 102, obturator 174 will be removed from fixed radius tube 160, and sheath 130 will be withdrawn from over expanded tubular braid 120, as seen in FIG. 19.
After expansion assembly 104 has been fully inserted through dilation assembly 102, inner coaxial rod 166 is removed from fixed-radius tube 160, and sheath 130 is removed from over expanded tubular braid 120.
Referring now in particular to FIGS. 20-22, delivery of a medicament to the target surgical site, through the access and delivery system of.the present disclosure, will be described in greater detail. After elongate dilation assembly 102 is in place, penetrating through skin "S" with the target surgical site insufflated with an appropriate gas and needle assembly 140 removed from dilation assembly 102, valve stem 138 is operatively and fluidly coupled to a source of medicament (not shown). As seen in FIG. 20, the surgeon then injects medicament "M", into passage 126 of handle 122 via lumen 139 of valve stem 138. With medicament "M" injected into passage 126 of handle 122 and the axial lumen of elongate dilation assembly 102, the distal end of elongate expansion assembly 104 is introduced into passage 126 of handle 122 through introducer seal 131 and advanced distally through tubular braid 120 and sleeve 134.
Turning now to FIG. 22, as expansion assembly 104 is further advanced distally, thereby further advancing medicament "M" through sleeve 134, medicament "M"
will encounter delivery holes 136 formed near the distal end of sleeve 134. As medicament "M" passes across delivery holes 136 of sleeve 134, medicament "M" will be forced radially outward through delivery holes 136 and to the target surgical site due to an expansion member insertion force "F", acting in a distal direction on medicament "M", and an insufflation pressure "P", acting in a proximal direction on medicament "M". The opposing insertion force "F" and insufflation pressure "P" will cause medicament "M" to be dispensed radially outward through delivery holes 136 of sleeve 134.
Referring now to FIG. 23, an alternative method of use of the access and medicament delivery system of the present disclosure, for performing a percutaneous penetration and for delivering a medicament to a target surgical site will be described.
With elongate dilation assembly 102 in place, penetrating through skin "S" and with the target surgical site insufflated and expansion assembly 104 fully received through tubular braid 120, valve stem 138 is operatively and fluidly coupled to a source of medicament (not shown). As seen in FIG. 23, introducer seal 131 creates a fluid-tight seal around a proximal portion of expansion assembly 104 while sealing cuff 135 creates a seal around a distal portion of expansion assembly 104.
According to the present embodiment, with expansion assembly 104 disposed within tubular braid 120 and sealed near its proximal and distal portions, the surgeon injects medicament "M" into passage 126 of handle 122 surrounding expansion assembly 104. Preferably, medicament "M" is a substantially non-viscous substance.
Accordingly, since introducer seal 131 creates a barrier at the proximal portion of expansion assembly 104, injection of medicament "M" into passage 126 will result in a distal flow of medicament "M", between sleeve 134 of dilation assembly 102 and expansion assembly 104, along tubular braid 120. Tubular braid 120 acts like a manifold, providing medicament "M" with a capillary of passages through which it can flow. Since cuff seal 135 surrounds expansion assembly 104 and creates a fluid-tight seal therearound, when medicament "M" approaches the distal portion of tubular braid 120, medicament "M" is forced radially outward through delivery holes 136 to the target surgical site.
Turning now to FIGS. 24-29, an expansion assembly constructed in accordance with an alternative embodiment of the present disclosure, is generally designated 204.
Expansion assembly 204 includes an expansion member (i.e., cannula) 206 and a proximal hub 208. Expansion member 206 includes a threaded connector 210 at its proximal end which can be removably secured to a fitting (not shown) in the distal end of proximal hub 208. Expansion member 206 defines a second cross-sectional area which is larger than the first cross-sectional area of sleeve body 12 and tubular braid 102.
In accordance with a preferred embodiment of the present disclosure, as seen in FIG. 24A and 24B, expansion member 206 of expansion assembly 204 is provided with a plurality of longitudinally running raised ribs 260 formed along the outer surface thereof.
As seen in particular in FIG. 24B, ribs 260 have a substantially triangular cross-sectional profile. As seen in particular in FIG. 24D, ribs 260 can have a substantially arcuate or semi-circular cross-sectional profile. Ribs 260 are preferably formed around the entire periphery of expansion member 206 and are evenly spaced from one another, as will be discussed in greater detail below.
Preferably, as seen in FIGS. 24B and 24D, six longitudinal ribs 260 are formed along the outer periphery of expansion member 206. While it is preferred that ribs 260 are evenly spaced from one another, it is contemplated that ribs 260 can be spaced any radial distance from one another. Preferably, a distal end of each rib 260 is tapered in height so as to facilitate the insertion of expansion assembly 204 into a proximal end of the lumen defmed by sleeve body 12.
As seen in FIGS. 24E and 24F, in an alternative embodiment, expansion member 206 of expansion assembly 204 can be provided with a plurality of raised bumps formed along the entire outer surface thereof. It is envisioned that bumps 264 can be hemi-spherical, conical, pyramidal or the like. Turning now to FIGS. 24G and 24H, in yet another alternative embodiment, expansion member 206 is provided with a helical thread 266 formed on the outer surface thereof. Preferably, helical thread 266 extends from proximal hub 208 of expansion assembly 204 to the distal end of expansion member 206, however, it is envisioned that helical thread 266 can extend any distance along the length of expansion member 206.
Turning now to FIG. 241, in an alternative embodiment, expansion member 206 is provided with a series of diagonally oriented ribs 268 formed along the outer surface thereof, which ribs 268 define a generally V-shaped or tread like arrangement.
Ribs 268 further define a plurality of channels 269 along the length of expansion member 206.
Needle assembly 140 is then removed, and expansion assembly 204 including an expansion member 206 and obturator 174 is introduced, as seen in FIG. 26, through introducer seal 131 and sleeve body 12 of dilation assembly 102, resulting in the radial expansion of sleeve body 12 of dilation member 108, as illustrated in FIG. 27.
Accordingly, introducer seal 131 acts to form a fluid-tight seal around a proximal portion of expansion member 206. With expansion member 206 in place within sleeve body 12 of dilation member 108, obturator 174 can be removed from expansion member 206, as seen in FIG. 28.
As seen in FIGS. 29A and 29B, ribs 260 cause the inner surface of sleeve body to tent up or be spaced a radial distance from the outer surface of expansion member 206.
Ribs 260 further define a plurality of longitudinally extending channels 300 around the periphery of expansion member 206 when expansion member 206 is in place within dilation assembly 102. Each channel 300 is bound by the outer surface of expansion member 206, the inner surface of sleeve body 12 and a pair of adjacent ribs 260. As will be described in greater detail below, it is contemplated that the access and medicament delivery system according to the present disclosure can be configured to deliver or inject a medicament "M", through channels 300, into the abdominal cavity of the patient.
Referring to FIG. 29C, bumps 264 act to space the inner surface of sleeve body a radial distance away from the outer surface of expansion member 206. Bumps reduce the contact area between the inner surface of sleeve body 12 and the outer surface of expansion member 206. Since the inner surface of sleeve body 12 only contacts the tips of bumps 264, the contact surface between the inner surface of sleeve body 12 and the outer surface of expansion member 206 is reduced, thus reducing the amount of force required to distally advance expansion member 206 through sleeve body 12.
Bumps 264 further act to define a single annular channel 302 surrounding the entire periphery of expansion member 206. It is contemplated that the access and medicament delivery system according to the present disclosure can be adapted to deliver or inject medicament "M" to the abdominal cavity through annular channel 302.
Referring now to FIG. 29D, helical thread 266 acts to space the inner surface of sleeve body 12 a radial distance away from the outer surface of expansion member 206.
Helical thread 266 reduces the contact area between the inner surface of sleeve body 12 and the outer surface of expansion member 206. Since the inner surface of sleeve body 12 only contacts the upper edge of helical thread 266, the contact surface between the inner surface of sleeve body 12 and the outer surface of expansion member 206 is reduced; the amount of force required to distally advance expansion assembly 204 through sleeve body 12 is reduced. Moreover, helical thread 266 aids in the distal advancement of expansion assembly 204 through sleeve body 12. It is contemplated that an expansion assembly 204 having an expansion member 206, with at least a single helical thread formed thereon, is distally advanced through sleeve body 12 by simply rotating expansion assembly around axis "X" (as seen in FIG. 26) in a screw type action thereby allowing helical threads 266 to draw expansion assembly 204 distally through sleeve body 12.
Helical thread 266 further acts to define an annular channel 304 surrounding the entire periphery of expansion member 206. It is contemplated that the access system according to the present disclosure can be adapted to deliver or inject medicament "M" to the abdominal cavity through annular channe1304.
As can be appreciated from FIG. 241, ribs 268 preferably act to direct, angle and/or channel medicament "M" through channels 269 and distally along the outer surface of expansion member 206.
While any number of ribs 260, 268, bumps 264 or helical threads 266 can be provided on the outer suTface of expansion member 206, it is preferred that the number of ribs 260, 268, bumps 264 or helical threads 266 be limited to as few as necessary in order to keep the contact surface between sleeve body 12 and expansion member 206 at a minimum and thereby keep the resistive forces, due to friction between sleeve body 12 and expansion member 206, to a minimum.
As discussed above, it is further contemplated that channels 300, 302 and 304 can be used to deliver medicament "M" into the abdominal cavity of the patient through the patient's skin "S". After expansion member 206 has been inserted into the abdominal cavity of the patient through dilation assembly 102, channels 300, 302 and 304 provide the surgeon with a passage through which medicament "M" can be injected or delivered into the abdominal cavity of the patient. Preferably, with expansion member 206 in place in dilation assembly 102, valve stem 138 is operatively and fluidly coupled to a source of medicament. The surgeon can then inject a medicament "M" into passage 126 of handle 122 via lumen 139 of valve stem 138, see FIG. 20. Since the proximal end of expansion member 206 is sealed by introducer seal 131 the injected medicament "M" will be forced to travel distally through channels 300, 302 and 304, between expansion member 206 and sleeve body 12, until it exits from the distal end of sleeve body 12, see FIGS. 27 and 28.
Referring now to FIG. 31, radially expandable dilation assembly 404 includes a sleeve body 12 and a handle assembly 20, as described above with reference to FIGS. 2-4.
In accordance with the present embodiment, as seen in FIG. 31, passage 16 of handle assembly 20 includes a pair of diametrically opposed bosses 422a, 422b extending radially inward from an inner surface 424 thereof. In a preferred embodiment, at least one of the pair of bosses 422a, 422b is provided with a lumen 426 having a proximal portion which opens in a direction substantially radially outward from handle assembly 20 and a distal portion oriented in a direction which opens into the lumen of sleeve body 12.
In a preferred embodiment, a valve stem 38 is operatively coupled to handle assembly 20 such that valve stem 38 is in fluid communication with lumen 426.
Each boss 422a, 422b is configured and adapted to be slidably received within and cooperate with a respective helical groove 460a, 460b of handle assembly 20.
Preferably, bosses 422a, 422b have a cross-sectional profile which substantially conforms to a cross-sectional profile of helical grooves 460a, 460b. As will be described in greater detail below, bosses 422a, 422b and helical grooves 460a, 460b screwingly cooperate with one another such that expansion assembly 402 is axially advanced through expandable dilation assembly 404 upon a rotation of expansion member 406. Preferably, the distal portion of lumen 426 of each of the pair of bosses 422a, 422b is oriented in a direction substantially co-linear with a pitch of helical grooves 460a, 460b. In this manner, as will be discussed in greater detail below, lumen 426 of one of the pair of bosses 422a, 422b is oriented to deliver a quantity of medicament "M" into and through a respective helical groove 460a, 460b. It is envisioned that each boss 422a, 422b can be provided with a respective lumen 426 configured and adapted to deliver a quantity of medicament "M" into both helical grooves 460a, 460b.
Referring now in detail to FIGS. 32-35, operation of access and medicament delivery system 400, including radially expandable dilation assembly 404 and expansion assembly 402, having the features disclosed above, will be described.
Initially, radially expandable dilation assembly 404, having a pneumoperitoneum needle assembly disposed therein, is introduced through the patient's skin "S" (or other body location) by engaging the sharpened distal end of needle assembly 140 against the tissue of the patient's skin "S" and advancing the sleeve/needle assembly forward until sleeve body 12 of dilation assembly 404 extends across the patient's skin "S".
Needle assembly 140 is then removed, and expansion assefnbly 402 including expansion member 406 and obturator 174, as described above, is introduced into sleeve body 12 of dilation assembly 404, resulting in radial expansion of sleeve body 12, as illustrated in FIGS. 34 and 35. Introduction of expansion assembly 402 into dilation assembly 404 is achieved by aligning the distal end of helical grooves 460a, 460b of expansion member 406 with bosses 422a, 422b of dilation assembly 404 advancing expansion assembly 402 distally until bosses 422a, 422b are received in helical grooves 460a, 460b, firmly holding handle assembly 20 of dilation assembly 404 to prevent rotation and/or proximal movement of dilation assembly 404 in the patient's skin "S", and rotating expansion assembly 402 in a screwing type action, about axis "X", in order to distally draw expansion member 406 and obturator 174 through the patient's skin "S" and to radially expand dilation assembly 404, from the first cross-sectional area to the second cross-sectional area.
As illustrated in FIG. 35, obturator 174 is then removed from expansion member 406, leaving an access lumen through the patient's skin "S" for the introduction of a variety of other surgical instruments therethrough.
In a preferred method of use, helical grooves 460a, 460b of expansion member are used to deliver medicament "M" into the target surgical site through the patient's skin "S". After expansion member 406 has been inserted through the patient's skin "S", through dilation assembly 404, helical grooves 460a, 460b provide the surgeon with an access channel through which medicament "M" can be injected into the target surgical site of the patient.
With expansion member 406 in place, valve stem 38 is fluidly coupled to a source of medicament (not shown). The surgeon then injects medicament "M" through valve stem 38, through lumen 426 of at least one boss 422a, 422b, distally through respective [0 helical grooves 460a, 460b, out the distal end of helical grooves 460a, 460b and into the target surgical site as needed. Medicament "M" is delivered through an access channel defined by the surfaces of helical grooves 460a, 460b and an inner surface of sleeve body 12 of expandable dilation assembly 404. Since introducer seal 131 creates a fluid-tight seal around expansion member 406, at a location proximal of bosses 422a, 422b, medicament "M" will be forced to travel distally through helical grooves 460a, 460b until it exits from the distal end of sleeve body 12. Alternatively, since bosses 422a, 422b have a cross-sectional profile which conforms to the cross-sectional profile of helical grooves 460a, 460b, bosses 422a, 422b act as stops which prevent medicament "M" from traveling in a proximal direction along expansion member 406.
In the preferred embodiment, a pair of diametrically opposed bosses 422a, 422b have been disclosed, however, it is envisioned that a single boss 422a or 422b can be used:
It is further envisioned that passage 16 of handle assembly 20 can be provided with either a single helical thread or a pair of diametrically opposed helical threads (not shown) configured and adapted to engage and be received in either one of or the pair of helical threads 460a, 460b. Further, while a lumen extending through at least one boss 422a, 422b is preferred, it is envisioned that valve stem 38 can open directly into passage 126 of handle assembly 20.
Therefore, the above description should not be taken as a limitation to the scope of the invention which is defined by the appended claims.
a radially expandable dilation assembly having a radially expandable sleeve body defining a lumen having a first cross-sectional area and a handle portion coupled to a proximal end of the sleeve body, the handle portion defining an aperture formed therein, and at least one engaging member integrally formed with the handle portion and including at least one boss projecting radially inward from the handle portion, wherein at least one of the bosses includes a lumen extending from an exterior of the handle portion of the dilation assembly through to the aperture formed in the handle portion;
an expansion assembly including an expansion member having an axial lumen with a second cross-sectional area, wherein the expansion member is configured and dimensioned to be selectively receivable within the aperture formed in the handle portion and within the lumen of the sleeve body, and at least one engaging element formed in an outer surface thereof, the engaging element including at least one helical groove for co-operable engagement with a respective engaging member of the dilation assembly, wherein the at least one engaging member of the dilation assembly cooperates with the corresponding engaging element of the expansion member to axially advance the expansion member through the dilation assembly upon a rotation of the expansion member; and a polymeric layer encasing the sleeve body.
3. The access and delivery system according to claim 2, wherein the radially expandable dilation assembly further includes a valve stem operatively coupled to the handle portion and being in fluid communication with the lumen formed in the boss.
4. The access and delivery system according to claim 3, wherein the handle portion of the radially expandable dilation assembly includes a seal extending across the aperture and disposed at a location proximal to the valve stem, wherein the seal forms to a fluid-tight seal around the expansion member upon insertion of the expansion member into the handle portion of the dilation assembly.
CA2454154A1 true CA2454154A1 (en) 2003-02-13
CA2454154C true CA2454154C (en) 2010-02-09