AU779087B2 - Insertion device - Google Patents

Description

AUSTRALIA

PATENTS ACT 1990 COMPLETE SPECIFICATION FOR A STANDARD PATENT

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S

ORIGINAL

Name of Applicant: Actual Inventor: Address of Service: Invention Title: HANSA MEDICAL PRODUCTS, INC.

Eric D. Blom, W. Gregory Chernoff and Daniel W. Karakla BALDWIN SHELSTON WATERS 60 MARGARET STREET SYDNEY NSW 2000 'INSERTION DEVICE' Details of Original Application No. 47910/96 dated 5 March 1996 The following statement is a full description of this invention, including the best method of performing it known to us:- -2- This invention relates to a method and apparatus for the delivery or placement of a device into an opening in a human body.

This invention relates to an improvement or modification in respect of an invention described in AU 655,520. The entire disclosure in the complete specification and claims of AU 655,520 is by this cross-reference incorporated into the present specification.

The improvement or modification relates to the delivery or placement of the device into any opening in the human body as opposed to delivery or placement solely into the tracheoesophageal wall.

~According to a first aspect of the invention, there is provided in 1. In ooo combination, a device for insertion into an opening in a human body, the device •including a resiliently deflectable device body having an insertion cross section transverse to its longitudinal extent which is insufficient to fill the opening and a larger use cross section transverse to its longitudinal extent, and a retainer for retaining the device body in its insertion cross section, the retainer being soluble in a fluid and S 15 removable to permit deployment of the device body to its use cross section.

According to a second aspect of the invention, there is provided a method for •inserting into an opening in a human body a device including a resiliently deflectable device body having an insertion cross section transverse to its longitudinal extent which is insufficient to fill the opening and a larger use cross section transverse to its longitudinal extent, the method comprising the steps of resiliently deflecting the device body, placing over the resiliently deflected device body a retainer soluble in a fluid, the retainer for retaining the device body in its insertion cross section, inserting the device with the retainer in place, and exposing the retainer to the fluid to deploy the device body to its use cross section.

-3- Unless the context clearly requires otherwise, throughout the description and the claims, the words 'comprise', 'comprising', and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is to say, in the sense of "including, but not limited to".

Illustratively accordingly to these latter aspects of the invention, the retainer is soluble in a fluid.

Additionally illustratively according to thee aspects, the invention further comprises means for, or the step of, introducing the fluid into contact with the retainer.

The term "cylindrical body", as used herein, means a body including a surface generated by a straight line parallel to another straight line moving in a closed path.

The invention may best be understood by referring to the following detailed description and accompanying drawings which illustrate the invention. In the drawings: Fig. 1 illustrates a fragmentary sectional view of the septum of a human nasal cavity, with the septum containing a septal button; Fig. l a illustrates a fragmentary sectional view of the septum of a human nasal cavity, with the septum containing a septal button; Fig. l b illustrates a fragmentary sectional view of the septum of a human nasal cavity, with the septum containing a septal button; Fig. 2 illustrates a fragmentary sectional view of the septum of a human nasal cavity, with the septum containing a septal button; Fig. 3 illustrates a fragmentary sectional view of the septum of a human nasal cavity, with the septum containing a septal button; Fig. 4 illustrates a fragmentary sectional view of a human nasal cavity; -4- Fig. 5 illustrates a fragmentary sectional view of a human nasal cavity; Fig. 6a illustrates a fragmentary sectional view of an ear tube; Fig. 6b illustrates a fragmentary sectional view of an ear with the ear tube positioned therein; Fig. 6c illustrates a fragmentary sectional view of an ear with the ear tube positioned therein; Fig. 7a illustrates a fragmentary sectional view of a silastic prothesis positioned in an opening in the skin; Fig. 7b illustrates a fragmentary sectional view of a silastic prothesis positioned in S. an opening in the skin; and Fig. 7c illustrates a fragmentary sectional view of a silastic prothesis positioned in an opening in the skin; In an embodiment constructed according to the invention, a septal button 200 has a central shaft 202 for plugging a perforation 204 in a nasal septum 206. Retaining flanges, cuffs or the like 208, 210 are provided at the ends of the shaft 202. Flanges, cuffs or the like 208, 210 are deployed to lie on opposite sides 212, 214, respectively, of the septum 206 when the septal button is in its use orientation, illustrated in Fig. 1.

However, this deployed orientation of flanges, cuffs or the like 208, 210 makes it somewhat difficult to manipulate the septal button 200 into the perforation 204. To overcome this difficulty, a thin-walled, somewhat collar- or right circular cylindricallyshaped, soluble, gelatin retainer 216 is provided. One, 210, of flanges, cuffs or the like 208, 210 is collapsed into an insertion-aiding orientation, illustrated in Fig. 2, and retained in that orientation by slipping retainer 216 over it. Because there may not be sufficient moisture in the nasal mucosa to dissolve the retainer 216, resort may be had to different techniques to achieve timely deployment of flange, cuff or the like 210 once the flange, cuff or the like 210 in its insertion orientation has been manipulated through the perforation 204.

According to one technique, the retainer 216 is very slightly pre-wetted, that is, exposed to a solvent such as mild saline solution prior to insertion into the perforation 204. This results in a somewhat more timely dissolution of the retainer 216 and deployment of the flange, cuff or the like 210. Pre-wetting makes the gelatin retainer 216 slightly slippery, which aides in insertion of the flange, cuff or the like 210 through .10 the perforation 204. Other solvents can be used to practice this technique. For example, a solvent can be employed that also functions as a lubricant for passage of the folded flange, cuff or the like 210 and retainer 216. An example of such a solvent is glycerol.

A solvent/lubricant aids in the passage of the folded flange, cuff or the like 210 and retainer 216 through the perforation 204 and reduces trauma to the perforation 204 and surrounding septal tissue 206. This technique requires some experimentation to determine implantation and dissolution times so that the flange, cuff or the like 210 does not deploy before it has passed through the perforation 204.

Another technique, illustrated in Fig. 2, that reduces the likelihood of premature deployment of the flange, cuff or the like 210 is not to introduce the solvent 218 until after the folded flange, cuff or the like 210 has been passed through the perforation 204.

In this technique, the solvent 218, for example, mild saline solution, is introduced into contact with the retainer 216, for example, by injecting 219 the mild saline 218 up the affected nostril 220 after the septal button 200 is in place in the perforation 204.

-6- As best illustrated in Figs. la-b septal buttons 200', 200" having different sized shafts 202', 202", respectively, can be provided for different sized perforations 204', 204", respectively. A single, somewhat larger size flange, cuff or the like 208, 210 can be used for all different sizes of shafts 202, 202', 202". Flanges, cuffs or the like 208, 210 can be cut to appropriate size prior to implantation.

Septal buttons 200, 200', 200" illustratively are constructed from resilient, medical grade silicones. However, Fig. 3 illustrates a non-permeable, non-absorbent, hypoallergenic closed cell foam septal button 200"' having flanges, cuffs or the like 210"' which can be folded and deployed in the same manner as described in connection with Fig. 2.

The present invention is also useful in inserting into passageways, ducts, organs, and the like, devices which are not provided with locating or retaining flanges, cuffs or the like. An example is illustrated in Fig. 4. Nasal packings and nasal packing insertion i tools are known and are in common use. An example is the 4.5cm nasal packing #400400 available from Merocel Corporation, Mystic, Connecticut 06355, and its inserter. The packings are treated to render them rigid. This aids insertion. The inserter itself includes an elongate, syringe-like rigid plastic probe. The nasal tissues into which these are inserted typically have experienced recent trauma, and are tender and susceptible to further trauma. That is why the nasal packings are needed. Although the packings soften as they begin to absorb fluids from the traumatised tissue and nasal cavity, they are rigid when they are inserted, and they have a tendency to harden again a few hours after they have been put in place. Sometime later, they must, of course, be removed.

-7- According to the invention, a soft, pliable, absorbent, open cell foam is fashioned into packings 224 having any appropriate cross-sectional configuration. The packings 224, when fully deployed (three are illustrated in Fig. are too large for convenient or comfortable insertion through a nostril 220 into a nasal cavity 222, particularly one which has recently experienced trauma. To remedy this, the packings 224 are compressed and inserted into thin-walled, sleeve-like, flexible gelatin retainers 226, Fig.

The packing 224-retainer 226 combination is flexible and of small enough cross sectional area, for example, to be inserted easily through nostril 220 into nasal cavity 222 .without causing significant trauma. The fluids which are the reason why the packings 224 are necessary dissolve the gelatin retainers 226 and aid the deployment of the Spackings 224.

SIn another embodiment of the invention illustrated in Figs. 6a-6c, an ear tube 310 for use in the treatment of certain diseases of the middle ear, such as serous otitis media, °has a cylindrical body portion 312 having a passageway 314 therethrough. A flange, cuff or the like 316 is provided at an end 318 of body 312 which will be on the outer ear side 320 of the tympanic membrane 322 of the wearer. The end 324 of body 312 which will lie on the middle ear side 326 of the tympanic membrane 322 of the wearer is provided with two arms 328 which, in their use orientations, illustrated in Fig. 6, extend transversely of the longitudinal extent of body 312. Illustratively, each arm 328 has a configuration similar to a lengthwise half of body 312. The arms 328 and body 312 are moulded in the configuration illustrated in Fig. 6a. The arms 328 are then deflected toward each other to the orientation illustrated in Fig. 6b, and a retainer 330 of the type described herein is placed over their adjacent ends 332, 334 to hold them in the -8configuration illustrated in Fig. 6b. The illustrated retainer 330 is soluble in, for example, fluids present in the middle ear 326, a lubricating gel or saline solution. In the situation in which the retainer 330 is soluble in a lubricating gel, such a gel is deposited onto the retainer 330 after ends 332, 334 are loaded into retainer 330 and before the assembly 310, 330 is inserted, ends 332, 334 first, through a tiny incision 336 made in the tympanic membrane 322 for this purpose. The gel dissolves the retainer 330 resulting in the deployment of arms 328 to their positions illustrated in Fig. 6a, fixing the tube 310 in tympanic membrane 322, providing a more or less permanent drain 314 for the middle ear 326 of the wearer.

10 Alternatively, and as illustrated in Fig. 6c, a hypodermic syringe containing saline solution 338 and fitted with a needle 340 can be inserted through passageway 314 once the assembly 310, 330 is inserted through incision 336. A small amount of the saline solution 338 is then dispensed into retainer 330 causing retainer 330 to dissolve and i resulting in the deployment of arms 328 to their positions illustrated in Fig. 6a and fixing the position of tube 310 in membrane 322.

In another embodiment of the invention illustrated in Figs. 7a-c, a silastic prosthesis 400 is provided for a patient 402 who has previously undergone a percutaneous endoscopic gastrostomy (PEG) 404. The prosthesis 400 has a cylindrical body portion 406 having a passageway 408 therethrough. A flange, cuff or the like 410 is provided at an end 412 of the body 406 which will lie adjacent the anterior abdominal skin surface 414. Another flange, cuff or the like 416 is provided at an end 418 of the body 406 which will lie adjacent the anterior wall 420 of the stomach. The flange, cuff or the like 416 is folded forward by, for example, the technique described in connection with Figs. 12-13 of Australian Patent 655,520, and a retainer 422 soluble in gastric fluids -9is placed over the thus-folded flange, cuff or the like 416 to retain it in the folded orientation. Once the end 418 of the prosthesis 400 containing the folded flange, cuff or the like 416 is inserted through the gastrostomy 404 into the anterior stomach 420, the retainer 422 dissolves, permitting deployment of the flange, cuff or the like 416 to its prosthesis-retaining orientation. The end 412 of the prosthesis 400 containing flange, cuff or the like 410 lying outside the abdomen of the patient 402 typically will be stoppered 426 when feeding, drainage or certain other treatment of the patient 402 is not being conducted. As in the other embodiments of the invention, deployment of the flange, cuff or the like 416 to its use orientation can be promoted by treating the retainer 422 with a lubricant/solvent before the end 418 of the prosthesis 400 containing the folded flange, cuff or the like 416 and retainer 422 is inserted into the gastrostomy 404.

Alternatively, and as illustrated in Fig. 7b, a small amount of a solvent such as, for example, saline solution, can be injected or otherwise introduced through passageway 408 into contact with the retainer 422 after the prosthesis 400 is in place in the gastrostomy 404.

Vo- •oo

Claims (6)

1. In combination, a device for insertion into an opening in a human body, the device including a resiliently deflectable device body having an insertion cross section transverse to its longitudinal extent which is insufficient to fill the opening and a larger use cross section transverse to its longitudinal extent, and a retainer for retaining the device body in its insertion cross section, the retainer being soluble in a fluid and removable to permit deployment of the device body to its use cross section.

2. The combination of claim 1 further comprising means for introducing the fluid into contact with the retainer. 10

3. A method for inserting into an opening in a human body a device including a resiliently deflectable device body having an insertion cross section transverse to its longitudinal extent which is insufficient to fill the opening and a larger use cross section transverse to its longitudinal extent, the method comprising the steps of resiliently deflecting the device body, placing over the resiliently deflected device body a retainer i 15 soluble in a fluid, the retainer for retaining the device body in its insertion cross section, inserting the device with the retainer in place, and exposing the retainer to the fluid to deploy the device body to its use cross section.

4. A device according to claim 1, substantially as herein described with reference to any one of the accompanying drawings.

5. In combination, a device and a retainer according to claim 1, substantially as herein described with reference to any one of the accompanying drawings. -11

6. A method for inserting into a first opening in a human body a device according to claim 4, substantially as herein described with reference to any one of the accompanying drawings. DATED this 17th Day of January 2002 HANSA MEDICAL PRODUCTS, INC Attorney: PAUL G. HARRISON Fellow Institute of Patent Attorneys of Australia of BALDWIN SHELSTON WATERS *o