Source: http://www.google.ca/patents/US20090287147
Timestamp: 2017-09-23 14:54:29
Document Index: 613777645

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

Patent US20090287147 - Apparatus and method for providing percutaneous access and medicament to a ... - Google Patents
A method of forming and enlarging a percutaneous penetration is provided. The method includes the step of providing a radially expandable dilation assembly having a needle assembly removably inserted in a axial lumen thereof. The radially expandable dilation assembly includes a radially expandable sleeve...http://www.google.ca/patents/US20090287147?utm_source=gb-gplus-sharePatent US20090287147 - Apparatus and method for providing percutaneous access and medicament to a target surgical site
Publication number US20090287147 A1
Application number US 12/266,758
Filing date 7 Nov 2008
Priority date 1 Aug 2001
Also published as CA2454154A1, CA2454154C, CA2684439A1, CA2684439C, DE60237899D1, EP1418850A2, EP1418850B1, US7449011, US8591466, US20040199121, WO2003011154A2, WO2003011154A3
Publication number 12266758, 266758, US 2009/0287147 A1, US 2009/287147 A1, US 20090287147 A1, US 20090287147A1, US 2009287147 A1, US 2009287147A1, US-A1-20090287147, US-A1-2009287147, US2009/0287147A1, US2009/287147A1, US20090287147 A1, US20090287147A1, US2009287147 A1, US2009287147A1
Inventors Thomas Wenchell, Robert C. Smith
Patent Citations (8), Referenced by (3), Classifications (16), Legal Events (3)
US 20090287147 A1
A method of forming and enlarging a percutaneous penetration is provided. The method includes the step of providing a radially expandable dilation assembly having a needle assembly removably inserted in a axial lumen thereof. The radially expandable dilation assembly includes a radially expandable sleeve body defining a lumen and an introducer seal disposed across the lumen and defining an opening formed therein. The method further includes the steps of penetrating the radially expandable dilation assembly and needle assembly through tissue to a target surgical site, withdrawing the needle assembly from the radially expandable dilation assembly, and inserting an expansion assembly through the opening formed in the introducer seal and into the axial lumen of the radially expandable dilation assembly.
1. A method of forming and enlarging a percutaneous penetration, the method comprising the steps of:
2. The method according to claim 1, wherein the radially expandable dilation assembly includes a handle assembly operatively coupled to a proximal end of the sleeve body, the handle assembly defines an aperture formed therein, and wherein the sleeve body is made up of a radially expandable tubular braid.
3. The method according to claim 2, wherein the sleeve body includes a polymeric layer encasing the tubular braid.
4. The method according to claim 3, wherein the dilation assembly includes a valve stem operatively coupled to the handle portion, the valve stem defining an injection lumen extending into the aperture formed in the handle portion.
5. The method according to claim 4, wherein the polymeric layer includes at least one radially oriented delivery hole formed therein.
6. The method according to claim 5, wherein the seal forms a fluid-tight seal around the expansion member upon insertion of the expansion member into the radially expandable dilation assembly.
7. The method according to claim 6, further including the step of injecting a fluid into the aperture of the handle portion after the expansion member is inserted into the dilation assembly, wherein the seal prevents the fluid from escaping from the proximal end of the dilation assembly and forces the fluid to flow distally through the dilation assembly.
8. The method according to claim 7, wherein the expansion member includes at least one radially projecting element provided on the outer surface thereof, wherein the at least one radially projecting element tents the sleeve body radially outward upon insertion of expansion member through the handle portion and into the sleeve body of the dilation assembly, wherein the radially projecting element defines at least one channel extending along the length of the expansion member when the expansion member is inserted in the dilation assembly, whereby the fluid flows along the at least one channel when the fluid is injected into the aperture of the handle portion.
9. The method according to claim 7, wherein the dilation assembly includes at least one engaging member integrally formed with the handle portion and projecting radially inward, and wherein the expansion member includes at least one corresponding engaging element formed in an outer surface thereof 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 rotation of the expansion member.
10. The method according to claim 9, wherein the engaging elements of the expansion assembly include at least one helical groove formed in an outer surface of the expansion member.
11. The method according to claim 10, further including the steps of: coupling the engaging member of the handle portion with the helical groove of the expansion member; and rotating the expansion member relative to the dilation assembly in order to axially advance the expansion member through the dilation member.
12. The method according to claim 11, wherein the fluid is injected through at least one of the engaging members into the corresponding helical groove such that the fluid flows out the distal end of the sleeve body via the helical groove.
The present application is a divisional of U.S. patent application Ser. No. 10/484,749 filed Jan. 21, 2004, which claims the benefit of and priority to International Application Serial No. PCT/US02/24308 filed on Jul. 31, 2002, which, in turn, claims the benefit of and priority to U.S. Provisional Patent Application Ser. No. 60/309,252 filed Aug. 1, 2001, the entire contents of each are hereby incorporated by reference.
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 VERSAPORT™. 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, the entire contents of which are expressly incorporated herein by reference.
The present disclosure relates to a method of forming and enlarging a percutaneous penetration. The method includes the steps of providing a radially expandable dilation assembly having a needle assembly removably inserted in an axial lumen thereof, penetrating the dilation assembly and needle assembly through tissue to a target surgical site, withdrawing the needle assembly from the dilation assembly and inserting an expansion assembly into the axial lumen of the dilation assembly.
Preferred embodiments of the presently disclosed radially expandable dilation assembly of an access system will now be described in detail with reference to the drawing figures wherein like reference numerals identify similar or identical elements. In the drawings and in the description which follows, the term “proximal”, as is traditional will refer to the end of the radially expandable sleeve of the present disclosure which is closest to the operator, while the term “distal” will refer to the end of the radially expandable dilation which is furthest from the operator.
Referring now in detail to the drawing figures in which like reference numerals identify similar or identical elements, a radially expandable dilation assembly of an access system is illustrated in FIGS. 1-4, and is generally designated 10. The presently disclosed radially expandable dilation assembly 10 contemplates the use of an introducer seal for the introduction of various types of surgical instruments through a handle assembly thereof, as will be described in greater detail below. Examples of such surgical instruments include, and are by no way limited to, trocars, cannulas, clip appliers, graspers, dissectors, retractors, staplers, laser fibers, photographic devices, endoscopes and laparoscopes, tubes and the like. Such instruments are collectively referred to herein as “surgical instruments”.
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 seal 26 clamped between lower and upper housing parts 22, 24 and extending across passage 16. Introducer seal 26 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.
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 seal 26, trocar “T” stretches opening 28 radially outward thereby creating a fluid-tight seal between the outer surface of trocar “T” and introducer seal 26. 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.
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.
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 reciprocatably received in the axial lumen of needle assembly 140. Obturator 148 is spring-loaded so that blunt end 150 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 is 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®).
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.
As seen in FIG. 21, distal advancement of expansion assembly 104 through sleeve 134 causes medicament “M” to be advanced distally through the axial lumen of tubular braid 120. In other words, expansion assembly 104 acts like a piston to drive medicament “M” distally through the axial lumen of tubular braid 120. Since tubular braid 120 is surrounded or encased by sleeve 134, medicament “M” is prevented from seeping radially outward through tubular braid 120. Further, introducer seal 131, which surrounds expansion assembly 104 and creates a fluid-tight seal around expansion assembly 104, prevents escape of medicament “M” from the proximal end of handle 122.
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.
While delivery holes 136 have only been shown on a single side of sleeve 134, as disclosed above, delivery holes 136 can be formed around the entire periphery of sleeve 134 in order to deliver medicament “M” in all directions in the target surgical site. It is further contemplated that is no delivery holes 136 are formed in sleeves 134 and if cuff seal 135 is not provided at the distal end of sleeves 34, 134, that medicament “M” will be ejected from the distal end of tubular braid 120.
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 120.
Referring now in detail to FIGS. 25-28, use of the access and medicament delivery system according to the present embodiment of the disclosure will now be described. As seen in FIG. 25, elongate dilation assembly 102, having pneumoperitoneum needle assembly 140 inserted therein, is shown penetrating through the patient's skin “S” and extending across the layers of tissue. Introduction of elongate dilation assembly 102 is accomplished as described above with reference to FIGS. 15-19.
As seen in FIGS. 29A and 29B, ribs 260 cause the inner surface of sleeve body 12 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 12 a radial distance away from the outer surface of expansion member 206. Bumps 264 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 204 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 channel 304.
As can be appreciated from FIG. 24I, 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.
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.
Each boss 422 a, 422 b is configured and adapted to be slidably received within and cooperate with a respective helical groove 460 a, 460 b of handle assembly 20. Preferably, bosses 422 a, 422 b have a cross-sectional profile which substantially conforms to a cross-sectional profile of helical grooves 460 a, 460 b. As will be described in greater detail below, bosses 422 a, 422 b and helical grooves 460 a, 460 b 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 422 a, 422 b is oriented in a direction substantially co-linear with a pitch of helical grooves 460 a, 460 b. In this manner, as will be discussed in greater detail below, lumen 426 of one of the pair of bosses 422 a, 422 b is oriented to deliver a quantity of medicament “M” into and through a respective helical groove 460 a, 460 b. It is envisioned that each boss 422 a, 422 b can be provided with a respective lumen 426 configured and adapted to deliver a quantity of medicament “M” into both helical grooves 460 a, 460 b.
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 140 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 assembly 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 460 a, 460 b of expansion member 406 with bosses 422 a, 422 b of dilation assembly 404 advancing expansion assembly 402 distally until bosses 422 a, 422 b are received in helical grooves 460 a, 460 b, 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 460 a, 460 b of expansion member 406 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 460 a, 460 b 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 422 a, 422 b, distally through respective helical grooves 460 a, 460 b, out the distal end of helical grooves 460 a, 460 b and into the target surgical site as needed. Medicament “M” is delivered through an access channel defined by the surfaces of helical grooves 460 a, 460 b 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 422 a, 422 b, medicament “M” will be forced to travel distally through helical grooves 460 a, 460 b until it exits from the distal end of sleeve body 12. Alternatively, since bosses 422 a, 422 b have a cross-sectional profile which conforms to the cross-sectional profile of helical grooves 460 a, 460 b, bosses 422 a, 422 b act as stops which prevent medicament “M” from traveling in a proximal direction along expansion member 406.
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U.S. Classification 604/99.04, 604/164.1
International Classification A61B1/313, A61B17/34, A61M29/02
Cooperative Classification A61B17/3474, A61B2017/349, A61B17/3431, A61B17/3415, A61B17/3421, A61B17/3462, A61B17/3439, A61B2017/3484, A61B1/313
European Classification A61B17/34G4H, A61B17/34G4
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:WENCHELL, THOMAS;SMITH, ROBERT C.;REEL/FRAME:021802/0672
21 Apr 2017 FPAY Fee payment