CA2014743C - Elongation of linear and tubular tissue - Google Patents

Elongation of linear and tubular tissue

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Publication number
CA2014743C
CA2014743C CA 2014743 CA2014743A CA2014743C CA 2014743 C CA2014743 C CA 2014743C CA 2014743 CA2014743 CA 2014743 CA 2014743 A CA2014743 A CA 2014743A CA 2014743 C CA2014743 C CA 2014743C
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CA
Canada
Prior art keywords
envelope
tissue
vessel
path
fluid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
CA 2014743
Other languages
French (fr)
Other versions
CA2014743A1 (en
Inventor
Amado Ruiz-Razura
Benjamin E. Cohen
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Individual
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Individual
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Filing date
Publication date
Priority claimed from US07/503,429 external-priority patent/US5083576A/en
Application filed by Individual filed Critical Individual
Publication of CA2014743A1 publication Critical patent/CA2014743A1/en
Application granted granted Critical
Publication of CA2014743C publication Critical patent/CA2014743C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Abstract

An inflatable envelope and a procedure for using it for the purpose of elongating tubular or linear tissue during the acute phase of a surgical procedure. The envelope has a path upon which the tissue is aligned, whose path length increases with inflation of the envelope. Successive inflations and deflations result in elongation of the tissue enabling re-connection of ends of the tissue which before were significantly spaced apart.

Description

2~ 43 2 Specification 3 Field of the Invention 4 This invention relates to elongation of linear and tubular tissue, for example blood vessels (tubular tissue) and nerves 6 ~linear tissue), in order that a defective portion can be 7 removed, and the remaining ends of the tissues may be directly 8 re~oined without interposition of a section of another vessel or 9 connective device, to provide connection for the tissue. Cross-Reference To Other Applications11 This application is a continuation-in-part of applicants 12 presently co-pending United States patent application Serial No.

13 07/48~,455, filed February 26,1990, entitled "Elongation Of Blood 14 Vessels", which is in turn a file wrapper continuation of applicants' then co-pending patent application Serial No.

16 07/340,431 filed April l9, l9~9, entitled "Elongation of Blood 17 Vesselsll~
18 Backqround of the Invention 19 This invention relates to the elongation of certain types Of tissue, namely linear and tubular tissue. Such tissue 21 constitutes many important parts of the human anatomy, which 22 parts sometimes become diseased or severed. Restoration of 23 function requires removal of diseased or damaged tissue, and 24 reconnection of the severed ends.

The problem with the reconnection is that there often is 26 insufficient remaining length of the tissue to enable a direct 27 reconnection, and parts of other similar tissue, or artificial 28 implants such as synthetic plastic tubing must be provided. Such 29 procedures can be very time consuming, especially when tissue must be harvested from some other part of the anatomy, and then 31 emplaced.
32 It is an object of this invention to enable tissue to be 3~ ~77 ~EIpr~ ~all~ rnad~in11 lab~
he Uni~9~ Sl-lG~ a~ 7 ~jrn'~ ,0 ~, ~I~r d,.,ld Ind~
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Z0~47hl3 1 elongated on an acute basis, during the operative repair 2 procedure, whereby to obviate the need for harvesting other 3 tissue. Then the duration of the procedure can be importantly 4 reduced. Reduction of time under anesthesia, and minimizing S invasive procedures, are of great importance to the patient, and 6 often are critical to his recovery.
7 Examples of the tissues subject to this invention are as 8 follows. Tubular tissue: veins and arteries (blood vessels), 9 fallopian tubes, vas deferens, ureters, urethras, limphatics, intestines, esophagus, and stomach. Linear tissue: muscles and 11 nerves. These are given by way of example, and not of 12 limitation, because there are others. These are all 13 characterized by shape or cellular construction such that linear 14 elongation is possible. This invention is not intended for ~ 15 expansion of skin, whose properties are quite different.
~ 16 Another problem with existing procedure is the need to make 17 two separate sutured butt-type joinders, each of which inherently 18 requires surgical effort and subsequent problems.
19 Still another frequently-encountered problem is the incorporation into the vessel of a body having different physical 21 or physiological properties at the abutting joinders. It is far 22 preferable to unite ends of identical tissue, rather than to 23 incorporate a structure having different properties. In many 24 situations the joinder of two ends which were formerly part of a continuous vessel, and whose locations were spaced apart, cannot 26 be accomplished merely by pu~ling the ends toward each other.
27 By way of further background, blood vessels will be given as 28 an example. The other tissues described function similarly with 29 this invention.

Blood vessels do have some elasticity which permits their 31 length to be varied somewhat. However, these vessels are not 32 simple structures. Instead they have at least several interior 42~0CP

2~14~
1 physiological layers as a lining which do not tolerate strong 2 compressive or gripping forces. Such forces can result in 3 bruises readily cause embollisms and clots. To grip a vessel 4 strongly and stretch it risks severe damage to the vessel.
However, a blood vessel inherently has sufficient elasticity 6 and y$eld within acceptable limits that an extension of perhaps 7 up to 50% can be attained. Thus, if the remaining portions of 8 the vessel can be permanently and sufficiently elongated to 9 reconstruct the excised length, then the ends to be joined can be in a nearly relaxed state. Of course this assumes that the 11 elongation did not harm the vessel, and especially its lining.
12 This requires a gradual and gentle procedure which does not 13 require a strong gripping force on the vessel, or any abrupt 14 stretching force. These objectives cannot be attained with known techniques and instrumentation, but they can be attained by means 16 of this invention.
17 When optimally used the device is expanded and relaxed at 18 least three times, and fragments of the lining or whatever which 19 may result from these forces can be washed out with the blood or whatever other fluid may be involved. Depending on 21 circumstances, only one or two expansions may be needed. In any 22 event, thi~ device enables the tissue to be elongated without 23 substantial trama.
~ 24 While considerin~ this invention, one should keep in mind that it is employed as part of a surgical procedure which almost 26 always involves general anesthesia. It is well-established that 27 morbidity of operations is strongly affected by the duration and 28 depth of the required anesthesia. Furthermore, the surgeon is 29 likelier to be fatigued by a procedure of longer duration than one of a shorter duration.

31 One significant example is the replacement of a portion of 32 the length of a coronary artery with a length of a vein taken ~ 147~ 3 from the leg. The harvestlng of the veln from the leg generally takes about 45 minutes to 1 hour. This is mostly because of the addltional separate procedure to obtaln the vein from the leg.
In contrast, when it can be employed, the procedure of thls inventlon can render the vessel transplant unnecessary. Further, lt can be accomplished ln only about ten to flfteen minutes under acute operatlve condltlons.
Brlef Descrlptlon of the Inventlon The inventlon provldes an lnflatable envelope for elongatlon of tubular or llnear tlssue, comprlslng, a closed fluid-impermeable envelope encloslng a chamber, said envelope belng flexlble and elastlc, and havlng an outer surface wlth a dimenslon whose length increases when the envelope ls inflated, the outer surface of said envelope having: (a) a smooth path along said dimension which enables free sliding movement between the tlssue and the path; (b) a surface modiflcation on the slde of the outer surface of the envelope faclng away from the path that lmpedes slldlng movement between the envelope and an anatomlcal support agalnst which it is to bear; (c) tlssue conflnement means at each slde of the said path over which the tissue will not slide freely, whereby the tissue tends to remaln allgned on sald path; and (d) a fill tube making a fluld connectlon with sald chamber to enable lniectlon of fluld into the chamber and withdrawal of fluld from the chamber, to inflate and to deflate the envelope.

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The envelope in use is placed immediately under the vessel, between supporting anatomy and the vessel, with the vessel aligned with that dimension. The envelope lnitlally is uninflated and has a low volume. Then the envelope is gradually expanded by in~ection of a fluid into it. As it expands, the vessel's length along the envelope increases with the envelope's increase of length along the dimension.
Because blood vessels are generally restrained against substantial longitudinal movement by attachment to bone, muscle or other supportive anatomy, placing the envelope between the vessel and the supporting anatomy, enlargement of the envelope will be effective in elongating the vessel. The vessel will have been detached from the supporting anatomy at the region to be elongated, but it will remain attached beyond this separate area so a stretching action will occur between them, and will not merely result in a general pull on the entire length of the vessel, which could frustrate localized elongation. At the same time, the restraint on the "fixed"
portions of the vessel will be those whlch it customarily has, and these are not pinching type grips. Thus, although grips could be provided to hold the vessel at each end of the envelope, they are not necessary.
It ls not best practice to stretch the defective portion of - 4a -42~0CP

- 2~ 7~

1 the vessel, because this portion will be discarded, and - 2 elongation of it confers no benefit. Accordingly this procedure 3 contemplates elongating a length of healthy tissue spaced from 4 the defective segment. Then when the defective segment is removed, that end of the vessel which has been elongated will be 6 pulled toward the resulting gap, and sutured directly to the 7 other end of the incision.
~ 8 The resulting vessel is not longitudinally stressed, and 9 includes only one abutment joinder. The number of sutured joinders has been reduced by half, there is no discontinuity in 11 the physical or physiological constitution of the repaired 12 vessel. It has been done quickly.
13 As simple as it appears, there are latent difficulties which 14 have had to be overcome. The device as used is not an implantation in the sense that the incision which enabled it to 16 be placed is closed. It is not closed. Especially for smaller 17 diameter vessels, the elongation process should take no more than 18 about lO to 15 minutes. Furthermore, it is not contemplated to 19 attach the vessel to the envelope. Accordingly, there is a substantial potential for the stretched vessel to slide 21 sidewardly off of the envelope.
22 Even more, the envelope rests upon supporting anatomy, and 23 the entire field is wet and slippery, and is irrigated during the 24 procedure. Downward pressure exerted by the stretched vessel on the top of the envelope could exert an eccentric force on the 26 envelope which could cause it to skid to one side.
27 In either or both of said events, the envelope and vessel 28 would not remain aligned so as to exert the stretching action.
29 In the brief procedure in an open incision contemplated by the invention, such events will quickly be noticed. More 31 importantly, the envelope itself is surfaced in such a way as to 32 reduce the risk of either such event. It should be noted that ZO~7~3 1 efforts have been made to elongate vessels with the long-term use 2 of expanding envelopes. These have actually been implanted and 3 the incision has been closed. The problem is that failure of the 4 assembly to maintain the proper alignment is not learned until the incision is again opened, and then the procedure is imperiled 6 had there been a failure. To strap the tissue in place is to 7 risk damaging the tissue. This invention avoids that risk.
8 Accordingly, the envelope according to this invention 9 includes surface means on the envelope which encourage the vessel to stay in place on the envelope and not slip off, and for the 11 envelope to remain in place relative to the supporting anatomy, 12 and not to slide or roll out from beneath the vessel.
13 The above and other features of this invention will be fully 14 understood from the following detailed description and the accompanying drawings, in which:
16 Brief Description of the Drawinqs 17 Fig. 1 is a longitudinal section showing the envelope 18 deflated and placed to elongate tissue, in this càse a blood 19 vessel;
Fig. 2 is a view as Fig. 1, showing the envelope inflated 21 and elongating the vessel;
22 Fig. 3 is a cross-section taken at line 3-3 in Fig. 2;
23 Fig. ~ is a top view of the envelope used in Fig. 1, 24 deflate~-Fig. 5 is a side view of Fig. 4;
26 Fig. 6 is a cross-section showing the envelope of Fig. 4, 27 inflated;
28 Fig. 7 is a side view of Fig. 6;
29 Fig. 8 is a fragmentary cross-section showing another embodiment of surface means to stabilize the vessel; and 31 Fig. 9 is a fragmentary side view, partly in cross-section, 32 showing an alternative to a reservoir.

-2~4~3 1 Detailed Description of the Invention 2 In Figs. 1-3, a blood vessel 10 having an axis 11 of 3 elongation is shown. It is a tubular conduit having an external 4 wall 12 and an internal lumen 13 through which the blood flows.
In its initial unstressed condition (Fig. 1), it lays along an 6 anatomic support or substrate 15 such as muscle or bone. This 7 relationship is shown only schematically.
8 It is intended to elongate the length of the vessel between g point A and point B. It is presumed that one of these points is not far distant from a defective segment 16 of the vessel, where 11 it is to be removed or from a missing segment, perhaps as the . ; 12 consequence of a trauma. The defective segment is to be cut at 13 planes E and F in Fig. 1, and ends 17, 18 of the vessel are to be 14 abutted and joined. The objective is to replace by elongation the length between planes A and B, the vessel length which is 16 excised between planes E and F.
17 The elongation occurs along the length of the segment to be 18 elongated. Initially as shown in Fig. 1, the longitudinal length 19 between planes A and B is denoted as C. In Fig. 2, after elongation, it is denoted as D. The difference in length between ~ 21 C and D is the elongation sought by this invention. It is 22 intended to be at least as long as the distance between planes E
23 and F, the segment 20 to be removed. After removal of segment 24 20, ends 17 and 18 are joined (or the other end of a damaged Vessel).
26 In order to elongate segment A-B a deflated envelope 30 is 27 initially placed between the anatomical support and the vessel, 28 as shown in Fig. 1. The envelope is made of material having 29 sufficient elasticity to expand as required without rupture. For service in the body, a medical grade silicon elastomer is 31 preferred. This is a material commonly used in tissue expanders 32 for expanding the skin. The envelope may have any desired l, 23ocl~

1 dimensions in plan view. Because of the procedures required, it 2 will usually have a limited width 31 (Fig. 4),and a length which 3 nearly appro~imates the stralght llne distat1ce between A and B.
4 W11atever the inltial shape may be, Up~11 inflation the envelope tends toward the ~pherical - no planar surfaces will 6 remain. The preferred shape is shown in Fig. 4. It is generally 7 rectangular wlth a dimension of width 31 and a dimension of 8 length 32 in the relaxed deflated condition.
g The envelope has a wall 35 which defines an internal cl1amber 36. A flll tube 37 enters this chamber from a reservolr 3~ as ll shown ln Figs. 1-7 or a valve as shown in Fig. 9. The reservolr 12 is made of a material which seals against a needle track. Tl1e 13 volume of a fluid in~ected into the reservoir will be equal ~o 14 that which enters the envelope to enlarge it. The enlargement i6 therefore known. ~lso, fluid withdrawn from the re~ervolr can 16 serve to deflate the envelope, as will be described below.
17 Fig. 9 showq an alternative to the reservoir. ~ valve 50 is 18 provided as a self-sealing fill port. It is a self-6ealin~
19 puncturable cap fitted over the end of the fill tube. It can be pierced by a syringe needle 51 through which fluid can be 21 ln~ected or removed. When the needle is withdrawn, its track 22 close~, and in this sense the cap is a valve. Other valves or 23 valve equivalents could also be used ln place of the reservoir.
2~ The envelope i5 preferably flat when deflated as sl1own in Figs 4 al1d 5, and enlarges as shown in Figs. 2,3,6 and 7.
26 With reference to Flg. 3, it will be noted that the vessel 27 has a nominal center 40, the envelope has a nominal center 4l, 28 and there is a center of contact 42 between the envelope and the 29 anatomical support. When these stay aligned, the device functlons optimally. sut if the vessel slips to one si~e of a 31 line drawn throug11 centers 41 and 42, lt will tend to slip off of ~2 the envelope and elongation will not occur.

4230cr - 20~7~, 1 Similarly, if the force exerted by the vessel on the 2 envelope is off of the line, there could be a tendency of the 3 envelope to slide to one side, and the vessel could slip off of 4 the envelope.
Also, because the length of the elongated vessel differs 6 from that of the envelope, it is best practice to permit the two 7 to slip relative to one another along the line of elongation.
~ ~ 8 For the above reasons, a path 45 along the dimension of 9 elongation is formed on the surface of the envelope which is smooth and offers no significant resistance to slippage of the 11 vessel on it.
12 On each side 46, ~7 of the top of the envelope, the surface 13 is treated by surface means so as to be resistant to lateral 14 slippage of the ve~sel. Raised studs along the edge of the path are one example. Preferably the sides will merely be roughened, 16 perhaps by heing formed in a die which has been sandblasted or 17 peened.
18 Also, the bottom 48 of the envelope which contacts the ~- 19 anatomical support will be similarly treated. Thus, the three element system is stabilized, and the vessel will remain in place 21 to be elongated.
22 Another embodiment of surface means to restrain the vessel 23 laterally is shown in Fig. 8. An envelope 55 in all other 2~ respects similar to those already described, has a groove 56 formed as the "path". The walls 57, 58 at each side of the 26 recessed groove provide the restraint. Even when the groove is 27 used, surface means at each side of it, and on the bottom, offer 28 advantages.
29 In this procedure, it is best practice to exert elongation forces incrementally, with relaxation between each incremental 31 exertion. This has two advantages. First it is better to 32 release the elongation force periodically to enable blood to flow

Claims (5)

1. An inflatable envelope for elongation of tubular or linear tissue, comprising, a closed fluid-impermeable envelope enclosing a chamber, said envelope being flexible and elastic, and having an outer surface with a dimension whose length increases when the envelope is inflated, the outer surface of said envelope having: (a) a smooth path along said dimension which enables free sliding movement between the tissue and the path; (b) a surface modification on the side of the outer surface of the envelope facing away from the path that impedes sliding movement between the envelope and an anatomical support against which it is to bear; (c) tissue confinement means at each side of the said path over which the tissue will not slide freely, whereby the tissue tends to remain aligned on said path; and (d) a fill tube making a fluid connection with said chamber to enable injection of fluid into the chamber and withdrawal of fluid from the chamber, to inflate and to deflate the envelope.
2. An inflatable envelope according to claim 1, in which a puncturable reservoir is connected to the fill tube to enable fluid to be injected into and removed from the envelope, from the reservoir to and from the fill tube.
3. An inflatable envelope according to claim 1 in which a valve is fitted to said fill tube to enable fluid to be injected or removed.
4. An inflatable envelope according to any one of claims 1 to 3 in which said path comprises a groove in said surface with a bottom and two side walls, said side wall comprising said tissue confinement means.
5. An inflatable envelope according to any one of claims 1 to 3 in which said tissue confinement means comprises studs on said surface.
CA 2014743 1989-04-19 1990-04-18 Elongation of linear and tubular tissue Expired - Fee Related CA2014743C (en)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US34043189A 1989-04-19 1989-04-19
US07/340,431 1989-04-19
US48845590A 1990-02-26 1990-02-26
US07/488,455 1990-02-26
US07/503,429 US5083576A (en) 1989-04-19 1990-04-02 Elongation of linear and tubular tissue
US07/503,429 1990-04-02

Publications (2)

Publication Number Publication Date
CA2014743A1 CA2014743A1 (en) 1990-10-19
CA2014743C true CA2014743C (en) 1998-08-25

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CA 2014743 Expired - Fee Related CA2014743C (en) 1989-04-19 1990-04-18 Elongation of linear and tubular tissue

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