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    US10130503B2 Original Document 20200704135624 PDF

    Uploaded by

    Raghavendra Singh

    Copyright:

    © All Rights Reserved
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    2 United States Patent Couch et al. US010130503B2 US 10,130,503 B2 Nov. 20, 2018 (a0) Patent No. 4s) Date of Patent: (54) CONICAL PoRT (76) lnventors: Christopher John Couch, Karnup (AU}: Robert Charles Patriek Hills, ‘Waikiki (AU) (*) Notice: Subject to any disclaimer, the erm of this patent is extended or adjusted under 35 USC. 1540) by 1331 days. (21) Appl.Nos 13824131 (22) PCY Filed: Sep. 19, 2011 (86) PCT No. §371 ©). (2), (4) Date PCTAU2011/001204 Jun, 10, 2013, PCT Pub, No: WO2012M34193 PCT Pub, Date: Mar, 2, 2012 7) (65) Prior Publication Data US 201340280338 AI Oct. 31, 2013, G0) Forcign Application Priority Data Sep. 17,2010 (AU) 2010904201 (51) Int. Ch AGIE 500 AGIM 3902 (200601) (2005.01) (Continued) (2) US.Cl CPC ABLE 570056 (2013.01); AGIM 390247 (2013.01); 461B 17/0087 (2013.01); (Continued) (68) Fleld of Classification Seareh CPC ns ABLM 39/0247; A6IM 2039/0261; AGIM 2030/0273; A6IM 2030/0282; (Continued) 66) References Cited US. PATENT DOCUMENTS 4393873 A T1988 Navash tal ADBII A S98S Kay ea (Continued) FOREIGN PATENT DOCUMENTS wo 93089 AL si1993 wo 172208 AL 102001, Primary Examiner — Theodore Stigell (74) Auornes, Agent, or Firm — Rothwell, Figg, Ernst & Manbeck, PC on ABSTRACT An access port comprising a port body anda catheter, the port body defining a cavity into which a Muid can be Selivered or extracted through one side ofthe port body, the catheter being in communication with the eavily and being disposed on an opposed side ofthe pot body, thus protecting the catheter from needle stick damage. An access. port comprising a port body anda catheter, the port body defining ‘cavity into which a fluid ean be delivered or extracted from through one side of the port body, the port body being configured to extend partly through & hoe inthe body of patient in which the access por is implanted and thus plug the said hole, The port body comprising integral moans for ‘anchoring the port body to the body of the patient. Also is provided a method for anchoring the access port to the hole ‘and extracting the aecess port fom the hole as well as the ‘applicator, extractor and delivery sheath for anchoring and extracting the access por. 21 Claims, 15 Drawing Sheets US 10,130,503 B2 Page? (51) Int, Ch. $911,706, AGIB 17/00 (2006.01), $997515 fain ize: (anosat san (52) US.CL 20050131325 CC gr 170233 2013.0, ao1M 20390201 Meh, (aotsonj tsi S0290275 001301 a6rMt Somers Dayar? Qoisol) ene (58) Field of Classification Search 016195 Coe nC AGIB'TMOIST Asp Iss, sip OORT Than, Aoib aoiraas, aotr soso UROL Corer spree cn snionarn (56) References Cited 20100312224 US. PATENT DOCUMENTS zonats2 4880980 871989 Mate al snisois 5287933 A+ 11/1903 Villswso ASI 1734 8912 5.688247 A 1/1997 Faint a * cited by examiner 4 8 < it Al al al al Al Al Al ale al alt a a 1999 11999 “2000 2002 520085 92006 42007 442007 72007 oe 52008 5200) s2010 1200 oon 72015 Esabrook et al dels Tore oa Willame Atala Chon ea Schule ea Muto tl, Dalton Glenn Burns etal Chants ta Paton uth eta. thot Honaryar Kala Asi 390247 cow isra2 SIM 39/1011 Go4'S33 ASIN 390208, 0x7 asin 2s02 Go 180 US. Patent Nov. 20,2018 Sheet 1 of 15 US 10,130,503 B2 FiG.2 *8 U.S. Patent — Nov. 20,2018 Sheet 2 of 15 US 10,130,503 B2 Prior Art FIG. 3 U.S. Patent — Nov. 20,2018 Sheet 3 of 15 US 10,130,503 B2 U.S. Patent — Nov. 20,2018 Sheet 4 of 15 US 10,130,503 B2 FIG. 6 U.S. Patent — Nov. 20,2018 Sheet 5 of 15 US 10,130,503 B2 U.S. Patent — Nov. 20,2018 Sheet 6 of 15 US 10,130,503 B2 FIG. 8 U.S. Patent — Nov. 20,2018 Sheet 7 of 15 US 10,130,503 B2 FIG. 10 U.S. Patent — Nov. 20,2018 Sheet 8 of 15 US 10,130,503 B2 212 FIG. 11 U.S. Patent — Nov. 20,2018 Sheet 9 of 15 US 10,130,503 B2 FIG. 12 U.S. Patent — Nov. 20,2018 Sheet 10 of 15 US 10,130,503 B2 FIG. 13 U.S. Patent — Nov. 20,2018 Sheet 11 of 15 US 10,130,503 B2 230 212 FIG. 14 U.S. Patent — Nov. 20,2018 Sheet 12 of 15 US 10,130,503 B2 205 291 FIG. 15b U.S. Patent — Nov. 20,2018 Sheet 13 of 15 US 10,130,503 B2 295 291 FIG. 16b FIG. 16a U.S. Patent — Nov. 20,2018 Sheet 14 of 15 US 10,130,503 B2 U.S. Patent — Nov. 20,2018 Sheet 15 of 15 US 10,130,503 B2 FIG. 18 283 283 US 10,130,503 B2 1 CONICAL PORT ‘CROSS REFERENCE TO RELATED "APPLICATIONS ‘This application is a 35 USC. § 371 National Phase Entry Application fom PCT/AU2011/001204, ld Sep. 19, 2011, and designating the United States, which claims privity under 35 USCC. $119 to Anstalian Patent Appl ‘ation No. 2010804201 ied Sep. 17,2010, which is incor ported herein in its entirety FIELD OF THE INVENTION This invention relates to an access port for delivery of 15 fui to patient ‘The invention bas been devised particularly, although not necessarily solely, for delivery of a fli into, or extraction ‘of a fluid from, a gastric band system for adjusting the astric band. The invention may, however, have other appi- 2 ‘cations for example, the invention may have applications in livery of uid sueh as medication or a treatment agent to 4 patient, or adjustment of a fluid volume in an implaat system within © patient “The patient need not necessarily be human, The patient may, for example, be an animal other than a human, in which ‘ase the invention may have veterinary applications. BACKGROUND ART x0 “The following discussion of the background art is iended 1o facilitate an understanding ofthe present inven- tion only. The discussion is aot an acknowledgement oF admission that any of the material refered to is or was part ‘of the common general knowledge a atthe priority date of the application Gastric band systems are implanted in patents: who typically suller from obesity. A gastric band system com- prises an inflatable band which is implantod around the Upper stomach and which is inflated or otherwise adjusted by way ofan access port implanted deep tothe skin of the patient. The access por includes a cater which commu- nicates with the gastic band and along which an ination fluid (such as a saline solution) is conveyed to inflate or ‘othervise adjust the inflatable band. ‘Typically, the access port comprises a port body defining ‘8 compartment for receiving the inflation uid. The com= partment contains a selfsealing closure which can be pen- ‘trated by an adjustment needle through which ination uid is delivered or extract. The closure typically comprises plug of silicone material. The port body has an outlet which ‘communicates with the compartment and from which a flexible tube extends for communication with the gastric band, The tube provides the catheter, The outlet is provided inthe side of the port body such thatthe catheter extends laterally from the port body. The port body has a fat bottom ‘which rests on the underlying tissue (e,2, musee'fascia) Implantation ofthe gastric ban system involves surgical incisions to access the abdominal cavity for installation of the gastric band and an extended surgical incision for installation ofthe port. The port is typically placed deep to the skin of the patient, being set on musclelfasia and secured in positon by stapling or suturing to the muscle! fascia ‘When itis necessary to inflate oF otherwise adjust the 6s sric band, a practitioner (typically « medical prettioner ‘or nurse) locates the port which is set deep wo the skin ofthe ” 4s © 2 patient and inserts the adjustment needle through the skin and into the self-sealing closure of the port to doliver or extract inflaton fui ‘While such ports have proved reasonably effective, there tare several deficiencies (One deficiency arses from the positioning of the catheter fn relation to the port body. Because the catheter extends Iaterally from the port body, the catheter is vulnerable to being pierced and damaged by the adjusiment needle in the event that the practitioner inadvertently misses the self- sealing closure during attempted insertion of the adjustment oad. Another deficiency i that the port body, which has a lat bottom, may have a tendency tilt or shift within the patient after implantation of the port, and even invert when in position, thereby causing difficulties in perfomning adjust- ‘ments t0 the implanted gastric band. ‘Yet another deficiency is that the part ofthe port body to ‘which te catheter is connected is rigid, thus creating @ point of stress at which the eatheter is prone to fracturing is against this background that the present inveat been developed. ‘Accordingly, itis an object ofthe present invention to ‘ameliorate one or more ofthe abovementioned deficiencies, or atleast provide an altemative access port DISCLOSURE OF THE INVENTION Acconding to a fist aspect of the invention there is provided an access port comprising a port body and a sathetr, the port body defining a cavity into which a hid can be delivered or from which a fluid can be extracted through one side of the port body, the catheter being in communication withthe cavity and being disposed on an ‘opposed side ofthe port boy Preferably, sud one side ofthe body i adapted to receive an adjustment need fr delivery ofthe fluid into the cavity. Prelerably the said one side is adapted for extraction of the Mui through said one side Preferably, the port body is adapted fo protect the atheter from the adjustment needle, by having the catheter disposed on theside ofthe port body opposed to that side to which the needle is presented for fuid adjustment Preferably, the port body comprises compartment hav ing a selfsealing portion which can be penetrated by an adjustment needle for delivery of fd to the eavity or for extraction of fui from the cavity Preferably, the port body comprises an outlet on said ‘oppose side which communicates with the cavity and from which the catheter extends Preferably, the opposed side of the body is of resilient construction to provide a flexible connection withthe cath- eter Preferably, the opposed side of the body is of resilient construction. Preferably the opposed side othe body is configured to at least party close a hole in the body ofa patient. Preferably, the ole comprises laparoscopic access hole inthe musce/esca ofthe patient Preferably, the opposed side ofthe body is configured as pl. Preferably, the opposed side of the body is adapted to close holes of various sizes. Preferably the body portion comprises a barrier to limit the depth w which a needle ean penetrate into the port US 10,130,503 B2 7 Preferably, the barier is pestioned within the cavity betwen said one sie ofthe port body and the opposite side ‘ofthe port body Preferably, the harrier comprises a butier plate supported in spaced relation with respect to the opposite side of the port body Preferably, the barrier plate comprises a plate formed of metal or any other appropriate hard material According to a second aspect of the invention there is provided an access port comprising @ port body and a catheter, the port body having first and second sides in ‘opposed relation, the first side being adapted to receive an ‘adjustment needle for delivery or extraction ofa fd, and scathoter disposed on the second sie to receive and convey the fd. According to a third aspect of the invention there is provided an access port comprising a port body, the port body defining a cavity into which a Muid can be delivered or from which a fuid can be extracted through one side of the port body, the body being configured to atleast partly close hole in the body of a patient. According to a fourth aspect of the invention there is provided an access port comprising a port body, the port body defining a cavity into which a Muid caa be delivered or from which a iuid can be extracted through one side of the port body, an outlet communicating with the cavity on an ‘opposed side ofthe port bod, the opposed side ofthe body being configured to atleast patly close a hole inthe body ‘of a patie According © a filth aspect of the invention there is provided an access port comprising a port body, the port body defining a cavity into which a uid canbe delivered or from which a fuid can be extracted through one side of the port body, a catheter communicating with the eavity on an ‘opposed side of the port bods, the opposed side of the port, body being configured to atleast patly close a hole in the body ofa patient. Preferably, the ole comprises laparoscopic access hole inthe muselefascia of the patient, According to a sixth aspect of the invention there is provided an access port comprising a port body, the port body defining a cavity into which a uid can be delivered or from which a uid can be extracted through one side of the port ody, a catheter communicating with the eavity on an ‘oppased side ofthe port bods, the opposed side of the port, body boing of resilient construction to provide a flexible ‘connection between the port body and the catheter According to a seventh aspect of the invention there is provided an access port comprising a port body into which a fluid can be delivered through one side of the port body, a catheter on an opposed side ofthe port body, wherein the ‘oppased side ofthe body is configured to atleast partly close bole in the body ofa patient, and wherein the opposed side ‘of the port body is of resilient construction to provide a exible connection between the port body and the catheter. Preferably, the flexibility of the flexible connection hetwaen the port body and the catheter increases progres- sively inthe direction away from the port body Preferably, the opposed side ofthe port body is of tapered ‘configuration facilitating the progressive increase in flex ibility of the connection between the port body and the catheter. Preferably, the port body is adapted to close holes of various sizes. This is possible because of the tapered con- figuration of the opposite side of the port ‘According to an eighth aspect ofthe invention there is provided aa access port comprising « port body and a 4 catheter, the port body defining «cavity into which a fad can be delivered or from which a fuid can be extracted through one side ofthe port boy, the catheter being adapted to receive and convey the ud, the port body’ comprising integral means for anchoring the port body tothe body ofthe patient Preferably, the means for anchoring comprises atleast one fist resilient member attached tothe port body and the at Jeast one fist resilient member being adapted 1 engage ata Jocation in the subcutaneous tisves for anchoring the port body to the body of the patient Preferably, each ofthe atleast one first resilient members is adapted 10 be deformed 10 a contracted condition for delivery of the resilient members to the heaton in the subeutaneos tissues of the patent Preferably, the body is configured to atleast partly close auhole inthe body ofthe patient Preferably the access port further comprises atleast one second resilient member being alaped to engage at a Iocation in the peritoneal cavity for anchoring the port body 10 the body ofthe patent, Preferably, each of the at lest one sevond resilient members is adapted io be deformed toa contracted condition for delivery of the resilient members 1 the location in the peritoneal cavity of the patent. Preferably, the port body comprises an opposite side configured to atleast partly close the hole, the at least one second resilient member being attache tothe opposite side of the port body orto the catheter. Preferably, the hole comprises hole in the muscle fascia ofthe patient, Preferably, the port body further comprises a membrane artached to the opposite side of the port body or to the catheter, the membrane being adapted to be collapsed for insertion inthe hole ofthe body of the patient and to be expanded to cover the peritoneal side of the hole. This rangement is particular useful because it reduces or elimi- nates the isk of herniation Preferably, the membrane comprises flexible membrane, Preferably: the membrane seals the hole. Preferably the port body further comprises a recoil device sitached to the opposite side ofthe pot body for insertion in tne hole, the recoil device being adapted for insertion in the hole. Preferably, the at feast one second resilient member is attached to the recoil device. Preferably the recoil device is adapted t0 expand and contract so a8 to vary the distance between the at least one first resiliont member and the at least one second resilient member. This is particulary useful during placement of the port. Also, the dimensions ofthe recoil device can adjust as the patient's weight change. According t0 a ninth aspect of the invention there is provided an applicator for applying an acces pot toa hole ina body of patint, the applicator comprising a body for containment of the aeess pot, the body of the applicator comprising a proximal end adapted to receive the access or, and a distal end comprising a resilient conical portion forinsertion inthe hole inthe body ofthe patent for delivery ofthe access port into the ole. Preferably, the proximal end ofthe applicator comprises at least one handle Preferably, the access ports an access port comprising a plurality of resilient members for snehoring the access port 'o the body ofthe patient. Preferably the body ofthe applicators adapted to receive snd eonfine the access port such that the plurality of resilient US 10,130,503 B2 5 members are in contracted condition for delivery of the saocess port t the bole in the body of the patient. Preferably, the resilient conical portion is adapted for insertion in the hole for delivery of at lest one of the plurality of resilient members into the peritoneal cavity af 5 the patient. Preferably, the applicator is adapted to receive an extrae- tor for delivery 0 the location of the access port far cexiaction of the access port According to a tenth aspect of the invention there is provided an extractor for extracting an access port from a hole in the body of the patient, the extractor comprising a body having a proximal end andl a distal end hingedly attached to the proximal end the distal end being adapted be located in a contracted condition for delivery to the hole in the body of the patent and adapted to be expanded for releasably engaging the access port Preferably, the proximal end of te extractor comprises at least one handle Preferably, the distal end comprises a plurality of barbs for attachment to the acess port to allow extraction of the sccess port by application ofa pulling force tothe proximal end. Preferably, the distal end comprises resilient material 2s allowing expansion of the distal end of the extractor for ‘engagement of the barbs to the access port. Preferably, the body comprises a cage defined by a plucalty of transversal and longitudinal struts. Preferably, the extractor further comprises an expansion system having a centre and a plurality of arms extending ‘outwarnlly ftom the centre, the arms being atached to the longitudinal stats to allow expansion of the distal end ducing expansion of the arms. Preferably, the ams comprise resilient material Preferably, the aems ate configured to expand the distal ‘end of the extractor upon application of a pressure to the ‘centre ofthe expansion system, According to eleventh aspect of the invention, there is provided a sheath for delivering an extractor to a hole in a body of a patient, the sheath comprising a body for con- ‘ainmeat ofthe extractor, the body of the sheath comprising ‘proximal end adapted to receive the extractor, and a distal ‘end comprising a resilient conical portion for insertion inthe hole in the body of the patient for delivery ofthe extractor 48 into the hole, Preferably. the proximal end of the sheath comprises at least one handle According to a twelfh aspect of the invention there is provided a method for anchoring an aecess port to a hole in a body of a patent, the access port having a plurality of resilgnt members, the method comprising the steps of: insertion of the access port in an applicator having @ resilient distal conical portion; of the aocess port 300, The inner stabilisers 214 ae attached tothe distal end 244 of the roooil device 242. The recoil device 242 is ‘adapted to receive the catheter 13, This allows the catheter 13 to extend from the lower portion 11b of the access port > and through the recoil device 242 for insertion into the ‘access hole duting application ofthe aocess port 300 on the muscleffascia 212 or into the subcutaneous tissue. ‘The recoil device 242 comprises resilient material. This means that the recoil device 242 may be deformed by ‘application ofa force, Once the force is remaved, the recoil device 242 retums to its normal condition. The nomal ‘condition of the eco device 242 is the contracted condi= tion. As sas proviously described with reference t0 the stabilisers 210, the tendency of the recoil device 242 to retuen to its normal condition provides reactive force ‘which opposes the force generated asthe reoil deviee 242 is expanded from is contracted condition. It is this force ‘which secures the access port 300 to the access hole 89 or ‘within the subcutaneous tissue, The aocess port 300 is particularly useful in eases where it is desired to postion the access port 300 at different distances from the muscl'fascia ofthe abdominal wall The access port 300 can be located at different distance from the rnuscelfascia 212 because the recoil device 242 can be ‘expanded up 16 a maximum size. In an arrangement where the reel device is being used, the aceess port 3100 may oaly ‘cover atleast partially the hole as the aecess port 300 may’ be simated some distance superficial to the hoe. Also, the access port 300 is capable of automatic adjust- ment as the patient experiences weight changes. For example, as shown in FIG. 6 the access port 300 may be located ona layer of fat 250 lying on the exterior side 230 ‘of the nusclelfascia 212, Ifthe patient loses weight and the thickness ofthe layer of ft 280 is reduced, the length of the recoil device 242 is also reduced. This is because, as mentioned befor, the recoil device 242 has a tendency to return to its normal condition. Reducing the length of the recoil device 242 maintains tension betwoen the inner and ‘outer stabiliser 214 and 216, respectively. This keeps the ‘access port 300 secured on the access hole 89 or in the Subcutaneous tissue ina relatively stabilised fashion Facing the skin ‘The recoil device 242 may comprise a eylindrcal body 282 comprising resilient material. Alternatively, the recoil device 242 may comprise a spring such asa helical spring. Other arrangements may include magnets. ” 4s © 4 Referring now to FIGS. 1 to 14 there are two arrange- iments for each of the access por 200 and access port 300. FIGS. 11 and 13 show a first aerangement ofthe access ports 200 and 300, respectively. FIGS. 12 and 14 show a second ‘arangemeat ofthe secess ports 200 aad 300, respectively. “The frst arrangement differs from the second arrangement in the manner ia which the inner stabilisers 214 ave positioned in their normal condition and in their deformed condition. In accordance with the frst arrangement of the access ports 200 and 300, the inner stabiliser 214 is attached to the lower portion 116 ofthe access port 200 andor the catheter 13 (orinthe case ofthe access port 300, to the distal end 244 ofthe recoil device 242) such that he resilient, members 232 of each of the stabilisers 214, in their normal condition, extend convexly towards the acess pot 200 (or 300), In this farangemeat, the stabilisers 214 are positioned in the deformed condition by folding the resilient members 232 over themselves. FIG. Hf shows the fist arrangement ofthe agcess por 200s itis mounted on the access hole 89, FIG. 1 shows the first arrangement ofthe access por 200 after having been mounted on the access hole 89. In accordance with the second arrangement of the access ports 200 and 300, the inner stabiliser 214 is attached to the lower portion I1b of the access port 200 andor the adjacent catheter 13 (or in the ease ofthe access port 300, te distal end 244 of the recoil device 242) such that the resilient members 282 of each stabilisers 214, in their deformed condition, extend opposite tothe access port 200 or 300. In this arrangement, the noma condition ofthe stabilisers 214 is such where the resilient members 232 extend concavely towards the access port 200 or 300, FIG. 12 shows the second arrangement ofthe access port 200 as itis mounted ‘onthe access hole 89. FIG, § shows the second arzangement of the acoess port 200 afier having heen mousted on the ageess hole 89. As mentioned before, any of the aecess ports in accor dance with the frst to fourth embodiment of the iaveation ‘may be adapted to be mounted on the access hole 89, The following descriptions of the methods for applying and removing the access port will be made with reference to the ageess port 200 in accordance with the thied embodiment of the invention, However, the methods for applying and removing the access port 200 can be applied to any of the ageess ports in accordance to the fist o fourth embodiment of the invention. Also, the methods can be used for other type of ports or other implanted devices used during gastric band surgical procedures and other procedures, Initially, an incision is made in the patieat's body. The incision is made such that it extends from the upper surface ofthe patients skin othe musee!fascia wall ofthe abdomi- nal cavity. After making the incision, the musclelascia bsominal wall is punctured inorder to form the access hole £89 for insertion of the lower portion 11D of the access port 200. (Once the incision andthe access hole 89 have been made, the access port 200s inserted into the incision and delivered to the aceess hole 89. At this sage the lower portion 116 of the aevess por 200 is inserted in the access hole 89. In order to insert the access port 200 into the incision and the lower portion 11b into the access hole 89, the outer and inner stabilisers 216 and 214, respectively, must be retracted to their deformed condition. Placing the stabilisers 210 into the deformed condition facilitates delivery of the access port 200 to the access hole 89 as well as insertion ofthe inner stabilisers 214 into the peritoneal cavity. Also, in the farangements of the secess port 200 which include the US 10,130,503 B2 15 membrane 238 (see FIG. 10), the membrane 238 must also be collapsed for insertion into the abdominal cavity. By inserting the lower portion 11b of the access port 200 inside the access hole 89, the ianer stabilisers 214 are positioned deep to the muscl'fascia 212 which surmounds the access hole 89, “The access port 200 may be applied to the access hole 89 ‘with the aid of an applicator 260, The applicator 260 is adapted to contain the access port 200 such thatthe stabi lisers 210 are forced into the deformed condition, This failitates insertion of the access port into the incision and delivery o the access hole 89. Aso, insertion of the ianer stabilisers 214 within the peritoneal cavity is facilitated because the inner stabilisers 214 are kept in the deformed condition during insertion of the lower portion 116 of the ‘cess port 200. ‘As mentioned before, the inner and outer stabilisers 214 and 216, respectively, have the tendency to retum to their normal condition when the force maintaining the stabilisers 210 in deformed condition is released. This means that when the ianee aad outer stabilisers 214 and 216, respectively exit the applicator 260, the stabilisers 214 and 216 tum to their normal conditions shown in FIGS. 8 t07 and FIG. 17. This secures the access port 200 on the access hole 89, ‘The applicator 260 comprises a cylindrical portion 262 tnd a conical portion 264 (ee FIG. 11). The dimensions of the eylindrical portion 262 and the conical portion 264 are such that the inner and outer stabilisers 214 and 216, respectively, of the access port 200 are collapsed to the ‘deformed condition when the access port 200 is positioned within the applicator 260, ‘The cylindrical portion 262 comprises an open end 268 ‘and handle 269, The open end 268 is adapted to receive the ‘access port 200, The conical portion 264 comprises an open ‘end 270 0 allow exit ofthe acess port 200 during insertion ‘of the lower portion I1b of the access port into the access hale 89 The cylindrical portion 262 and the conical portion 264 ae integrally connected to define the applicator 260, The ‘ylindrical portion 262 comprises a rigid eylinder 266. The igi cylinder 266 may be of any material such as metal, plastic, among others ‘The conical portion 264 facilitates insection ofthe appli- ‘ator 260 into the acess hole 89. The conical portion 264 is, ‘made out of resilient material. This allows expansion of the ‘conical portion 264 in oder to facilitate exiting ofthe access port 20. FIGS. 1 to 14 show the method for applying the access port 200 and 300 to the access hole 89 or applying the acess port 300 to the subcutaneous tissue (in the case of access Port 300), In particular, FIGS. 11 and 12 show the application ofthe first and second arrangements, respectively, of the access port 200 in accordance with the thiel embodiment. And, FIGS. 13 and 14 show the application ofthe frst and second arrangements, respectively, ofthe access port 300 in accor- dance with the fourth embodiment Reterring to FIG. 11, intially the access port 200 together ‘withthe catheter 13 are inserted into the applicator 260. This may be done through the open end 268 of the cylindrical portion 262, Altermatvely, the aocess port 200 may be inserted into the applicator 260 through the open end 270 of the applicator 260, “The access port 200 is Tocated within the applicator 260 such thatthe catheter 13 extends out from the open end 270 © 16 of the conical portion 264. In this way, the catheter 13 can suid the conical portion 264 through the incision and into the access hoe 89. Subsequently, the applicator 260 i inserted into the patient's body. Prior to this however the catheter 13 will already have been connected t0 the gastric band catheter. Catheter 13 isthe inserted inthe patients body followed by the applicator 260. As mentioned before te eatheter 13 juides the apliator 260 into the incision and the acess hole 89. Also tension fom the inside ofthe peritoneal eavity canbe applied tothe estheter 13 by using a inr-petonal sraser to assist the positioning the conical end of the Spplicatoe 260 into the access ole 89. Once the conical potion 264i located within the access hole 89, the access port 200 can be applied on the access hoe 89. This can be aevomplished by applying a pressure the upper portion Ma ofthe acces port 200. The presire applied to the upper portion La of the acess port 200 may be applied by piston or the sureon's finger. Simultane- ously, the conical portion 264 ofthe applicator 260 may be extracted from te access hole 89by applying paling force tothe handle 26 of the applicator 260. As shown in FIG. 1, by aplying the pressure, he sceess port 200 i pushed though the conical portion 264 ofthe spplicatoe 260 sich that the inner stabilisers 214 are posi tioned deep to the musclefaseia 212 which surounds the acces bole 89. Simultaneously, the applicator 260 is with. drain by applying a pling force to the handle 269. A this stage te inner stabilisers 214 ae located in 3 condition such that te stabilises 214 are within the peritoneal cavity and axe in contact with or ae lose to the innerside 228 of the nuscleifascia 212. After the access port 200 his sparse fom the appli caior 260, the outer stabilisers 216 are dsplacod fom the contacted condition 10 a condition in which the outer stabilisers 216 rein close proximity to the outer side 230 of the muscllfsci 212, (Once deployed within the body, the inner and outer stabilisers 214 and 216, respectively, sanwich the muscle! fascia 212 n this manne, the acess port 200s secured to the access hole #9, as previously described A this stage, the applicator may be extracted from the “Moreover, on occasions the access port 200 or 30 may noo tobe replaced a removed, Removal of the acoess port 200 oF 300 may be performed by sing an exractor 280 ss shown in FIG. 1§ and ia FIG. 16 ‘The extractor 280 comprises a proximal iid eylindical body’ 282 anda distal expandable body 286, The proximal "iid body 282i defined by a purity of rigid longitinal au iid transversal strats 281. The struts 281 are attached to each other such a8 to define a cage like structure. The distal expandable ody 286s defined by a purity of rigid longitudinal struts 283 and plurality of expandable trans- verse struts 284 ‘handle 288i atachod to the proximal rigid eylindical body 282. The distal end of the expandable body 286 comprises a plurality of barbs 289. wil be deseribed with reference othe method for exacting the access por 200 or 300, te barbs 289 are adapted to arab the sees port 200 or 300 The extractor 280 comprises resilient material such os pstic or metal, among others. ‘The distal expandable body 286 is hingedly ache to the proximal rigid body 282. The fact thatthe transverse strats 284 in the distal expandable body 286 are expandable sn that the distal expandable body 286 and the proximal US 10,130,503 B2 17 rigid body 282 are hingedly connected, allows the distal body 286 of the extractor 280 to be expanded from a ‘contracted condition (ee FIG. 18) to an expanded condition (see FIG. 16). Inthe expanded condition, the distal expand able body 286 of the extractor 280 hus » greater diameter than when the distal expandable body 286 is in the con- tracted conkition. As will be destibed with reference to the method far extracting the access ports 200 or 300. te fact that the diameter ofthe distal expandable body 286 of the ‘exirctor 280 can he varied facilitates grasping ofthe access Port 200 or 300 by the extractor 280 ‘The diameter of the distal expandable body 286 may be ‘expanded using an expander, such as, an inflatable expand. Also, a pision may used to inerease the diameter ofthe distal ‘expandable body 286, Further extraction ofthe aooess port 200 oF 300 from the ‘access hole 89 is performed using a sheath 290 adapted to allow the extractor 280 (see FIG. 16) wo slide into it, Altematively, the applicator 260 (used for applying the ‘access port 200 or 300 to the access hole 89) may be used ‘98a sheath for extraction of the access port 200 or 300, ‘The sheath 290 comprises «rigid proximal eylindrcal body 294 and distal expandable body 293 and ahandle 296 attached to the rigid proximal cylindrical body 294. The handle 296 allows manipulation of the sheath 290 into and ‘out ofthe incision. ‘The distal expandable body 293 comprises rigid longiti- inal struts 291 with intervening elastic material 298, The distal expandable body 293 is hingedly attached 10 the proximal rigid body 294, The fact thatthe elastic material 298 berween each longitudinal strt in the distal body is ‘expandable and that the distal expandable body 293 is hingedly atached to the proximal rigid body’ 294 allows the ‘expandable distal body 293 ofthe sheath 290 to be expanded from 2 contracted condition (see FIG. 18) to an expanded ‘condition (see FIG. 16). Inthe expanded condition, the distal ‘expandable body 293 of the sheath 290 has a greater «diameter than when the distal expandable body’ 293 is inthe ‘contracted condition. As will be described with reference to the method for extracting the access port 200 o¢ 300, the Fact that the diameter ofthe distal expandable body 298 of the sheath 290 can be varied facilitates the introduction of the ‘extractor 280 down the sheath 290 and into position to allow grasping ofthe access port 200 or 300 by the extractor 280, ‘The sheath 290 is aclapted to receive the extractor 280 and the access port 200 oF 300, As will be described with reference to the method for extracting the port, the extractor 280i slid into the sheath 290 prior extraction of the acess pont 200 or 300, During extraction of the access prt 200 or 300, the access port 200 or 300 (Iogether with the stabilisers 210 and membrane 238, if the membrane 238 is included) is ‘drain into the sheath 290. The sheath 290 restains the stabilisers 210 and membrane 238 (ifthe membrane 238 is included) from retuming to their normal position during ‘extraction of the access port 200 or 300, This fecilitates ‘exiicton of the extractor 280 and the access port 200 or 300. The sheath 290 may be of any material such as plastic, among others. ‘The method for removing the access ports 200 or 300 is shown in FIGS, 18 and 16. Initially, an incision is made in the patent's body. The incision may be at the location where the incision was previously made during placement of the access port 200 or 300 which now will be removed or replaced. The depth of the incision must be such as o provide access to the acess port 200 or 300 to be removed. ” 4s © 18 After the incision has been mad, the extractor 280 is located superficial to the access, port 200 or 300, This is accomplished by inserting the extractor 280 into the sheath 200, The sheath 290, including the extractor 280, is intro- {duced into the incision and delivered tothe access port 200 or 300, ‘The distal expandable bodies 286 and 293 ofthe extractor 280 and the sheath 290, respectively, are expanded while the extractor 280 and sheath 290 are located superficial to the aveess port 200 or 300. In the expanded condition, the extractor 280 is mounted on the access port 200 or 300 allowing attachment of the barbs 289 to the lower portion Ib of the access port 200 or 300 (see FIG. 16). After attaching the barbs to the lower portion 115 the diameter of the distal expandable bodies 286 and 293 of the extractor 280 and the sheath 290, respectively, may be reduced in ‘order thatthe barbs 289 are secured to the access port 200 or 300. In this manner, the extactor 280 is releasable tached tothe access port 200 or 300. The diameter of the distal expandable hodies 286 and 293 of the extractor 280 ‘and the sheath 290, respectively, are reduced by, for example, deflating the expander or retracting the piston. The distal expandable body 293 of the sheath 290 which is covering the distal expandable body’ 286 of the extractor 280 will expand and contract synchronously with the expansion ‘nd contraction of the distal expandable body 286 of the extractor 280, AL this tage, the access port 200 of 300 can be extracted from the acces hole 89, Ths is accomplished by pulling the extractor 280 in order to draw the access port 200 or 300 (Qogether with the stabilisers 240 and membrane 238, ifthe ‘membrane 238 is included) further into the sheath 290, Once the access port 200 or 300 (Cogether with the stabilises 210 ‘and membrane 238, if the membrane 238 is inclnded) is contained withia the sheath 290, the sheath 290 may be extracted from the patent's body by pulling the handle 296 of the sheath 290 in order to retrieve the sheath 290 including the access port 200 or 300 aad the extractor 280. FIGS. 18 to 20 show an altemative arrangement of an extractor 400 for extracting the access port 200 or 300 from the access bole 89. The extractor 400 may be used in conjunction wit the applicator 260 or wit the sheath 290 for extraction ofthe access port 200 or 300. ‘The extractor 400 according to the alternative arrange- ‘ment has some similarities tothe extractor 280 and similar reference numerals are used to identify similar parts ‘The extractor 400 comprises a proximal rigid cylindrical body 282 and distal expandable body 286, In arrangement, the distal expandable body’ 286 is hiagedly attached to the proximal rigid cylindrical body 282. A handle 288 is ‘tached tothe proximal end ofthe proximal rigid eylindi- cal body 282. The distal end 286 comprises a plurality of barbs 289. As willbe described with reference tothe method! or extracting the access port 200 or 300, the barbs 289 are adapted to grab the aceess port 200 or 300. ‘The proximal cylindrical body’ 282 ofthe extractor 400 is rigid cylinder. The distal end 286 of the extractor 400 comprises resilient material. The extractor 400 may be ‘manufactured from metal or plastic, among other suitable materials “The fact thatthe distal end 286 comprises resilient mate- rial allows the distal end 286 of the extractor 400 10 be expanded fom a contracted condition to an expanded con- ition. Inthe expanded condition, the distal end 286 of the extractor 400 bisa larger diameter than whea the distal end 286 of the extractor 400 sin the contracted condition. As Will be described with reference to the method for extracting US 10,130,503 B2 19 the access port 200 or 300, the fact thatthe diameter of the distal end 286 of the extractor 400 can be varied fecilitates trasping ofthe access pors 200 or 300. “The extractor 400 comprises an expander system 402. The ‘expander system 402 is located tthe distal end 286 ofthe cexiracior 400, The expander system 402 is adapted to ‘expand the diameter ofthe distal end 286 of the extractor 400, The expander system 402 may be activated by a finger. ‘The expander system 402 comprises a centre 404 and a plurality of arm members 406 extending outwardly from the ‘centre 404. The arrangement shawn in FIG. 20 shows the ‘expansion system 402 having four arm members 406. The ‘arm members 406 surround the centre 404 at spaced loca- tions with respect to each other. Each arm member 406 ‘comprises an end attached to the centre 404 and an end attached to the longitudinal cage struts 283 of the extractor 400. ‘The am members 406 comprise resilient material. This allows the arm members 406 to bend] and thereby convert the ‘dowawand force applied by a finger to a lateral force that, Separates the longitudinal cage stuss 288 radially, thereby ‘expanding the distal end 286 of the extactor 400. ‘As mentioned before, the expander system 402 allows ‘expansion of the distal end 286 of the extrictor 400, The ‘expansion ofthe distal end 286 is accomplished by pushing. > the centre 404 of the expansion system 402 via a finger. Pushing the conte 404 resiliently defoems the arms 406 from the non deformed condition tothe deformed eondition. ‘The arms 406 in the deformed condition expands the distal end 286 of the extractor. “The method for removing the access port 200 or 300 is shown in FIGS, 18 and 19, The present method utilizes the ‘applicator 260 in conjunction with the extractor 400, How: ‘ever, as mentioned before, the aceess port 200 or 300 may be extracted using the sheath 290 Aso, te following descriptions ofthe method for remov- ing the access port will be made with reference tothe access por 200 in accordance to the thitd embodiment of the invention, However, the method for removing the access pon 200 can be applied to aay of the access ports in ‘accordance tothe first to fourth embodiments of the inven- tion. Also, the method can be used for other types of ports used during gastic band surgical procedures and other procedures and other implant devices. As previously explained, initially, an incision is made in the patent's boy. The incision may beat the Tocation where the incision was previously made during placement of the access port 200 which now will be removed or replaced, The ‘depth the incision must be such as o provide acess tothe access port 200 to be removed. ‘Afr the incision has been made, the extractor 400 is located supericial to the acoess port 200, This is aecom- plished by inserting the extractor 400 into the applicator 260, ‘The applicator 260, inchuding the extrctor 400, is inte «duced ino the incision and delivered tothe acess port 200. ‘The distal end 286 of the extractor 400 is expanded and this simultaneously expands the surrounding conical portion 264 ofthe applicator 260 while the extractor 400 is located immediately superficial to the access port 200, The distal ‘end 286 of the extractor 400 is expanded throvgh the ‘expander system 402, The expander system 402 expands the

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