WO1990012543A1

WO1990012543A1 - Method and apparatus for hemostasis and containment of a bleeding internal bodily organ

Info

Publication number: WO1990012543A1
Application number: PCT/US1990/002202
Authority: WO
Inventors: Nabil A. Atweh
Original assignee: The Research Foundation Of State University Of New York
Priority date: 1989-04-27
Filing date: 1990-04-23
Publication date: 1990-11-01
Also published as: US5057117A

Abstract

The present invention concerns methods and apparatus for containment of, and carrying out hemostasis, of, a massively bleeding internal bodily organ of a patient. Generally, the apparatus comprises a flexible compartment-defining structure (1) having physical dimensions sufficient to generally conform to the gross geometry of a substantial portion of the organ. The flexible compartment-defining structure has an inner and outer surface, and is configurable so as to surround and contain a substantial portion of the organ, with the inner surface facing the external surface of the organ. The apparatus of the present invention can be used to carry out hemostasis and/or the collection of blood for reprocessing and subsequent introduction to the patient by auto-transfusion. In another embodiment of the present invention, apparatus manipulates the surface-temperature of an internal bodily organ. Such apparatus further includes a flexible fluid-containable structure (27) disposed over a substantial portion of the outer surface of the flexible compartment-defining structure, and is adapted for the passage of a gas or fluid therethrough in order to control the surface-temperature of the organ. In yet another embodiment of the present invention, a computer-graphic modelling (60) and computer control (50, 35) system are provided in order to programmably control the surface-temperature and surface-pressure of the organ, while carrying out the methods of the present invention.

Description

METHOD AND APPARATUS FOR HEMOSTASIS AND CONTAINMENT _C OF A BLEEDING INTERNAL BODILY ORGAN.

BACKGROUND OF THE INVENTION Field of the Invention.

The present invention relates generally to methods an apparatus for controlling bleeding from internal bodil organs, and/or manipulating the surface temperature o pressure thereof. More particularly, the present inventio relates to method and apparatus carrying out hemostasis retrieval of shedded blood, and other functions utilizing device which surrounds the internal bodily organ.

Setting for the Invention In published reports by the National Center For Heal Statistics, accidents including trauma, rank as leading cau of death in the age group 15-34 in the United States.

"Trauma, blunt or penetrating, civilian or militar continues to be a major cause of bleeding and drainage hospital and blood bank resources, with major loss of hum life.

Solid abdominal organs are frequently injured by blu and penetrating abdominal trauma. The peritoneal cavity does not provide adequate tamponade to stop bleedi -> from solid abdominal organs.

Several surgical techniques have been developed aimi at the control of bleeding from injured liver, spleen, kidn and other organs. These include suturing, resection a devascularization of the organ. A large number of live ~ spleen and renal injuries do not respond to the techniques, leading to death of the patient or sacrifice of valuable organ.

Major elective surgical procedures on the liver other solid organs may also result in massive uncontrollab 5 bleeding, contributing to the high morbidity and mortalit associated with these procedures.

Known techniques for control of major bleeding from th liver include:

(1) suture ligation;

(2) surgical or radiographic devascularization, ;

(3) resection; and

(4) packing of the peritoneal cavity. Inspite of the above-mentioned techniques, mortalit 0 from major liver injuries remain very high and is associate with high morbidity related to massive transfusions hypothermia and coagulopathy which contributes to th drainage of health care resources.

In two articles published in the Journal of Trauma,

--5 Volume 26, No. 8, 1986, entitled "Liver Packing Fo

Uncontrolled Hemorrhage: A Reappraisal", by R. Ivatury, e al., and "Packing For Control Of Hepatic Hemorrhage", by

D. Fβliciano, et al. , packing for massive liver bleeding ha been described as a last resort when all other hemostati

?0 techniques fail. However, such a method of hemostasis ha numerous shortcomings and drawbacks. For example:

1) the anatomy of the liver and other soli abdominal organs does not yield itself to adequat compartmentalization utilizing packing techniques;

5 2) extensive amount of packs are needed leadin to an increase in ^' intra-abdominal pressure, an consequently, compromising the patient's ventilation;

3) this technique is incapable of adequatel saving shedded blood for the purpose of autotransfusion;

-* 4) this technique does not allow for th manipulation or otherwise control of the pressure applied t the bleeding organ during a process of attempting to achiev tamponade; and

35 5) the extensive foreign body effect relating t the liver packing of the peritoneal cavity leads to majo septic complications.

Bleeding from the spleen, kidney, uterus and othe organs can also lead to exsanguination. Several techniques have been applied to control bleeding from these organs

However, it is not infrequent that in desperation, sacrific of the organ is undertaken to salvage the patient's life a a price of a major morbidity due to a loss of a valuabl organ. In recent times, salvaging the spleen has become o major importance in the pediatric as well as the adul population since the medical community has learned more abou the manifestations and consequences of post-splenectom sepsis.

For the past two decades, attempts at splenic salvag have included:

1) suturing techniques, which are occasionall successful;

2) embolization of the splenic artery; and

3) wrapping the spleen with omentum and/o absorbable mesh material in the aim of ta ponading t bleeding and/or covering the row surface that is bleedin

However, like packing, prior art spleen wrappi techniques do not allow for controllable manipulation pressure on the organ, provide a liquid seal around t organ, or allow for the monitoring, collection, processi and reinfusion of shedded blood, among other things.

In a similar fashion, trauma to the kidney or intern bleeding from the uterus as due to post partum complicatio and other pathological processes, may lead to the sacrifi of the organ, after the application of alternati techniques fail.

Accordingly, in view of the shortcomings and drawbac of prior art methods and apparatus for achieving hemostas in massively bleeding organs, there clearly is a great ne for new methodologies and apparatus which improve th salvage of human lives and are capable of achieving such function while decreasing morbidity and preserving muc needed human blood and other hospital resources.

Therefore, it is a primary object of the presen

-^ invention to provide a method and apparatus fo compartmentalizing an organ, and having the potentia capability of applying controlled pressure to achiev control of the bleeding from an organ such as the liver spleen, kidney, uterus and other organs. 0 It is a primary object to the present invention t provide a method and apparatus aimed at controlling and/o collecting the blood shedded from a solid organ, fro whatever cause, but most commonly due to trauma or surgery for the purpose of monitoring and autotransfusion. ^ It is another object of the present invention t provide a novel method of managing frequently fatal clinica situations, and is expected to result in a decrease in th amount of blood transfusions needed to stabilize traumatized internal bodily organ, and thus contribute t 0 saving lives.

Another object is to provide a method and apparatus f carrying out hemostasis of a hemorrhaging bodily organ which the method is performed in an operating room a enables a traumatized patient to be rapidly stabilized pri 5 to being moved to another institution, with less danger uncontrolled hemorrhage.

A further object of the present invention is provide apparatus for achieving hemostasis of a hemorrhagi intra-abdominal organ, without compromising other org ° functions, such as respiration, or applying (i. transmitting) pressure to other intra-abdominal or thorac organs.

A further object of the present invention is to provi apparatus which can be easily fabricated as a self-contain 35 disposable unit.

Another object of the present invention is to provi apparatus capable of manipulating the organ surfac temperature.

Yet an even further object of the present invention

^• 5^ to provi.de apparatus for compartmentalizi.ng an i»ntern bodily organ and being capable of achieving other function while being easy to apply and remove from the body.

Other and further objects of the present invention wi be explained hereinafter, and will be more particular 0 delineated in the dependent claims and other objects of the present invention will be apparent to those with ordina skill in the art to which the present invention pertains.

SUMMARY OF INVENTION

^■^ The present invention concerns a method and apparat for compartmentalizing an internal bodily organ. In genera the apparatus of the present invention comprises a flexib compartment-defining structure having physical dimensio sufficient to generally conform to the gross geometry of 0 substantial portion of the organ. The flexible compartmen defining structure has an inner and outer surface and configurable so as to surround the compartmentalized porti of the organ, with the inner surface facing the exter surface of the organ.

-^•5 In one embodiment of the present invention, a flexi expandable receptacle means is disposed over a substant portion of the inner surface of the flexible compartme defining structure, and is positionable between the flexi compartment-defining structure and the organ. The flexi

3° expandable receptacle means is capable of containing volume of gas or liquid and expanding in response thereto, as to expand and thereby apply a distribution of pressure the external surface of the organ while a substantial port of the organ is surrounded by and compartmentalized wit 35 the flexible compartment-defining structure, generall conforming to the gross geometry of the organ. Preferably the flexible compartment-defining structure is made of material which is impervious to blood, and includes a seali means for bringing and sealing together the peripheral edg of the flexible compartment-defining structure, so as to fo a compartment for surrounding a substantial portion of t organ, and having an opening for accommodating the extensi of vital anatomical structures associated with the organ.

In one embodiment of the present invention, t compartment-defining structure of the apparatus hereof al includes at least one port formed therein, for the purpose draining shedded blood which is collected within t compartment formed by the flexible compartment-defini structure surrounding the organ. The port includes connection means for connecting a tube to the port, and one embodiment, an auto-transfusion means is connected to t other end of the tube so that blood collected within t flexible compartment-defining structure is passed on to t auto-transfusion means for processing and subseque reinfusion of the blood into the patient.

In one embodiment of the present invention, t flexible compartment-defining structure includes an out flexible layer and an inner flexible layer which are join together in order to form the flexible expandable receptac means hereof. In particular, the outer flexible layer made up of substantially non-elastic material which impervious to gas and/or liquid, and has physical dimensio sufficient to generally conform to the gross geometry of t organ. The inner flexible layer is made of a materi impervious to gas and/or liquid, and like the outer flexib layer, has physical dimensions sufficient to general conform to the gross geometry of the organ. The inn flexible layer is hermetically sealed to the outer flexib layer, and overlaps adjacent portions thereof so as to fo the flexible expandable receptacle means hereof. In such embodiment, the inner flexible layer forms the inner surfa of the flexible compartment-defining structure, whereas t outer flexible layer forms the outer surface of the flexib compartment-defining structure.

The hermetic sealing of the inner and outer flexib layers at overlapping adjacent portions, is preferab achieved in accordance with predetermined patterns a configurations in order to form the flexible expandab receptacle means. In one embodiment, the patte configuration comprises a plurality of spaced-apart circle all of which are enclosed by a boundary adjacent to t perimeter edges of the layers, and an expandable chamber formed between a substantial portion of flexible layers whi is capable of being filled with a volume of gas or liqui The flexible expandable chamber is disposed over substantial portion of the inner surface, and when fill with air or liquid, expands so as to apply a distribution pressure to the external surface of the organ wh partially surrounded by and compartmentalized in the flexi compartment-defining structure hereof.

In one embodiment of the present invention, a seal means is also provided to the flexible compartment-defin structure for the purpose of bringing together and provid a liquid seal around the perimeter portions thereof, when flexible compartment-defining structure is configured so to surround and compartmentalize a substantial portion of organ.

In one embodiment, the apparatus of the pres invention further includes a supply of gas or liquid in fl communication with the flexible expandable receptacle mea

Alternatively, however, a pump and tubing can be used to f the flexible expandable receptacle means with air in order cause the flexible expandable receptacle means to expand apply pressure to the external surface of the or surrounded by the flexible compartment-defining structure.

Another aspect of the present invention is to provi apparatus for compartmentalizing an internal bodily orga and therewhile to control the surface-temperature thereof a controllable fashion. In such an embodiment, the out surface of the flexible compartment-defining structure has flexible fluid-containable receptacle means disposed over substantial portion thereof, and is capable of containing fluid or a gas, to be passed therethrough. In th embodiment, an organ surface-temperature supply and contr means is provided, and includes a circulation means, and supply of liquid or gas in fluid communication with t flexible fluid-containable receptacle means. T circulation means circulates the liquid or gas through t flexible fluid-containable receptacle means and a temperatu ^" control means is provided for controlling the temperature the fluid or gas being circulated through the flexible flui containable receptacle means.

~In order to monitor the surface-temperature of t organ, a plurality of surface temperature sensing means a 0 disposed on the flexible compartment-defining structure. T organ surface-temperature control means is capable programmably controlling the temperature of the gas or liqu in response to the surface-temperature of the organ, sens by the surface-temperature sensing means. In order

^•-⁵ monitor the surface-temperature of the organ, a monitori means is provided, and a display means is also provided f displaying the surface-temperatures thereon.

Another aspect of the present invention concerns a w station for use in conjunction with the above-descri 0 apparatus hereof. The work station has the capability modelling in real-time, the organ which is compartmentali within the flexible compartment-defining structure here and displaying the same on a visual display monitor, al with detected organ surface-pressures, organ surfa 5 temperatures and monitored shedded blood flow rates as wel

A user control interface is provided to the work station that a health professional can programmably control a monitor, from the work station the organ surface-temperatur surface-pressure, and shedded blood flow rates. 5

Using the apparatus of the present invention, one more functions can be carried out by compartmentalizing internal bodily organ of the patient which is massiv bleeding, according to the principals of the prese invention.

In particular, the present invention provides a meth of carrying out hemostasis and blood collecti simultaneously using for example, the apparatus of present invention. The present invention also provides method of controlling the surface-temperature of a sol 5 organ using another embodiment of the apparatus hereof.

As a result of the present invention, the shortcomi and drawbacks of the prior art methodologies have b overcome, and a significant contribution to the surgical a has been made. 0

BRIEF DESCRIPTION OF THE DRAWINGS

For a full understanding of the objects of the pres invention, reference is made to the following detai description of the preferred embodiments which is to be ta -5* in connection with the accompanying drawings, wherein:

Fig. 1A is an anterior view of the human anat showing a portion of the skeletal system, the periton cavity, and the liver situated therein;

Fig. IB is a posterior view of the human anat ^•J showing a portion of the skeletal system, the periton cavity, and the liver situated therein;

Fig. 1C is a side view of the human anatomy showin portion of the skeletal system, the peritoneal cavity, the liver situated therein; 35 Fig. 2 is a side view of the liver as positioned belo the diaphragm and in front of the esophagus, in th environment of the aorta Inferior vena cava and spin column.

Fig. 3 is a posterior view of the liver showing t left and right triangular ligaments coronary ligaments a the falciform ligament which must be severed to partial detach the liver from the diaphragm, and other peritone structures.

Fig. 4 is a posterior view of the liver shown in Fi 3, with the compartment-defining apparatus of the prese invention surrounding and compartmentalizing a substanti portion thereof, while vital anatomical structures, such the inferior vena cava and "portal triad" (i.e. the bi duct, hepatic artery, and the portal vein) are dispos outside of the compartment-defining apparatus;

Fig. 5A is a plan view of one embodiment of t apparatus ^' of the present invention for surrounding a compartmentalizing a substantial portion of the liver, sho in an unassembled state to illustrate its hermetically-seal double-wall construction;

Fig. 5B is a perspective posterior view of t apparatus illustrated in Fig. 5A, shown fully assembled;

Fig. 5C is a cross-sectional view of the apparat shown in Fig. 5B, taken along line 5C-5C with a cros sectional representation of the liver shown interposed a compartmentalized within the volumetric-space defined by t inner walls of the compartment-defining structure hereof;

Fig. 6A is a plan view of a second embodiment of t apparatus of the present invention, showing the flexib compartment-defining layer disposed substantially in tw dimensions and having dimensions sufficient to general conform to the gross geometry of a substantial portion the liver, with the flexible expandable receptacle mea disposed over a substantial portion of the inner surfac Fig. 6B is a perspective view of the apparatus shown Fig. 6A, in which the flexible compartment-defining structu thereof is configured and a portion of its perimeter edg brought and sealed together so as to enclose a thre dimensional space within which a liver can be surrounded a compartmentalized within the peritoneal cavity;

Fig. 7A is a plan view of a third embodiment of t apparatus of the present invention, showing the flexib compartment-defining structure disposed substantially in tw dimensions and having physical dimensions sufficient generally conform to the gross geometry of a substanti portion of the liver, with the flexible expandab receptacles disposed over a substantial portion of the inn surface;

Fig. 7B is a perspective view of the apparatus sho in Fig. 7A, in which the flexible compartment-defini structure thereof is configured and a portion of i perimeter edges brought sealingly together so as to enclose three-dimensional space within which a liver can partially surrounded and compartmentalized within t peritoneal cavity;

Fig. 7C is a cross-sectional view of Fig. 7B ta along line 7C-7C;

Fig. 8A is a plan view of a fourth embodiment of apparatus of the present invention, showing the flexi compartment-defining structure disposed substantially in t dimensionals and having physical dimensions sufficient generally conform to the gross geometry of a substant portion of the liver, with the flexible fluid-containable structures disposed over a substantial portion of the ou surface of the compartment-defining structures;

Figure 8B is a perspective view of the apparatus sh in Fig. 8A, in which the flexible compartment-defin structure thereof is configured and a portion of perimeter edges brought together so as to enclose a thr dimensional space within which a liver can be surrounded a compartmentalized within the peritoneal cavity;

Fig. 9 is a block function system diagram of y another embodiment of the present invention, in whi compartmentalization of an internal bodily organ can carπed out under controllably monitored organ surfa pressure conditions while recovering shedded blood from t bleeding organ for auto transfusion, in addition to providi organ surface-temperature monitoring and control, and thre dimensional computer modelling of the organ and the real-ti visual display thereof along with measurements of monitor organ surface-pressure, organ surface-temperature, and flo rates of collected shedded blood.

Fig. 10A is a view of the spleen shown after bei mobilized by incising its anatomical attachments to t peritoneum, kidney, stomach, colon and greater omentu leaving the splenic hilar structures (i.e. splenic artery a vein and tail of the pancreas) undisturbed;

"Fig. 10B is a perspective view of the spleen shown Fig. 10A, with the embodiment of the compartment-defini apparatus hereof adapted for the spleen, surrounding a compartmentalizing a substantial portion thereof while vit anatomical structures, such as the splenic artery and v and pancreas, are disposed outside of the compartme defining apparatus;

Fig. 11A is an anterior view of the kidneys sh after being mobilized by incising the overlying periton attachments and Gerota's Fascia, leaving the renal hi (i.e. renal artery and vein and renal pelvis) undisturbed;

Fig. 11B is an anterior view of the kidneys shown

Fig. 11A, with the embodiment of the compartment-defin apparatus hereof adapted for a kidney, surrounding compartmentalizing a substantial portion thereof, while vi anatomical structures of the organ, such as renal artery vein and renal pelvis and ureter, are disposed outside the compartment-defining apparatus;

Fig. 12A is a graphical representation of a cross section of the uterus showing the peritonealized portio thereof, fallopian tubes, ovaries and cervix; and

Fig. 12B is a graphical representation of the uteru shown in Fig. 12A, with the embodiment of the compartment defining apparatus hereof adapted for the uterus, surroundin and compartmentalizing a substantial portion thereof, leavin the fallopian tubes, ovaries and cervix disposed outside o the compartment-defining apparatus.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE PRESENT INVENTION

Referring to Figs. 5A, 5B, 5C, 6A, 6B, 7A, 7B, 8A an

8B, in particular, the detailed description of th compartment-defi.ni.ng apparatus of the present i.nvention f surrounding an internal bodily organ, will be given below follows.

"In general, the apparatus of the present inventi comprises a flexible compartment-defining structure 1 havi physical dimensions sufficient to generally conform to t gross geometry of a substantial portion of an orga

Notably, in the embodiments illustrated in Figs. 5A, 5B, 5

6A, 6B, 7A, 7B, 8A and 8B, as herein disclosed, the organ a liver of a human patient, however, apparatus constructed accordance with the principles of the present invention, intended for use in connection with other organs as wel including the spleen, kidney, and uterus. These oth embodiments of the present invention are illustrated in Fig

10A, 10B, 11A, 11B, 12A, and 12B, respectively, and will described hereinlater.

While the flexible compartment-defining structure 1 m be constructed using a variety of construction technique there are however, structural requirements that should satisfied in order to carry out the methods of the prese invention, as will be described hereinafter.

One such structural requirement is that the flexib compartment-defining structure 1 be in fact (i) flexibl

(ii) have an inner and outer surface, and (iii) configurable so as to surround and compartmentalize substantial portion of a traumatized organ so that the inn surface thereof, faces the external surface of the organ.

In Fig. 5B, one embodiment of the apparatus f surrounding an internal bodily organ such as the liver of patient, is shown in the form of a jacket-like assembly comprising outer flexible layer 2 and an inner flexib layer 3 joined together in a manner described in Fig. 5A.

The outer flexible layer 2 is made of a substantial non-elastic material which is impervious to gas or liqui and most particularly, impervious to blood, and has physic dimensions sufficient to generally conform to the gro geometry of the liver (not shown) . The inner flexible lay 3 is made of a material impervious to gas or liqui particularly shedded blood, and has also physical dimensio sufficient to generally conform to the gross geometry of t liver.

Referring to Figs. 5A and 5C in particular, the inn flexible layer 3 is hermetically sealed (along broken line to the outer flexible layer 2 at overlapping adjace perimeter edge portions thereof, so as to form a flexib expandable receptacle means 4. Notably, in this embodime the flexible expandable receptacle means 4 is realized as t flexible expandable chamber, or bladder, formed between t two flexible layers 2 and 3 as clearly illustrated in Fi

5C. After the flexible expandable chamber 4 is formed, t double-walled chamber in the compartment-defining structure with expandable chamber 4 realized therein, is folded up itself about the x-axis shown in Fig. 5A, and correspondi points along the perimeter edges A' and A and B¹ and B brought and sealed together so as to form the "jacket-li compartment-defining structure 1 illustrated in Fig. 5B.

While the embodiment shown in Figs. 5A, 5B and 5C h realized as a flexible bladder or chamber 4 formed betwe the inner and outer flexible layers 2 and 3, respectivel this flexible bladder or chamber 4 shall be referred hereinafter and especially in the claims, as the flexib expandable receptacle means hereof.

Notably, with such construction, the inner flexib layer 3 of the flexible compartment-defining structure 1 formed from the inner surface thereof, whereas the out flexible layer 2 of the compartment defining structure 1 formed from the outer surface thereof.

The flexible expandable chamber 4 is disposed over substantial portion of the inner surface and is positionab between the flexible compartment-defining structure 1 and t organ. The flexible expandable chamber 4 is capable containing a volume of gas or liquid under pressure, applying a distribution of pressure to the external surf of the liver, while a substantial portion of the organ surrounded by and compartmentalized within the flexi compartment-defining structure 1, generally conforming to gross geometry of the liver.

As shown in Figs. 5B, apparatus l of the pres invention includes an opening 5 formed in the flexi compartment-defining structure 1. The opening 5 apparatus of Fig. 5B provides an opening through which mobilized liver can be inserted into the expandable thr dimensional volume (i.e. compartment) defined by the flexi compartment-defining structure 1 of the present inventi As will be described in greater detail hereinafter, portal triad of the liver and inferior vena cava is allo to extend from opening 5 when the compartment-defin structure surrounds and compartmentalizes a substant portion of the liver. In order to reduce the size of opening 5, the embodiment in Figs 5A and 5B is provided w a "purse string" type closing device formed by a fine slee 6 formed at the perimeter defining edges D' and D of openi 5, through which a purse string 7 or functionally li structure is weaved therethrough, to create a purse strin like mechanism. Upon applying the apparatus 1 of the prese

-

^J invention about a traumatized liver, with the portal tri and inferior vena cava extending from the opening 5, t purse string 7 can then be pulled so as to reduce t opening 5, so that the compartment-defining structure snugly fits about the organ, as desired. 0 In order that the flexible expandable chamber 4 of t jacket-like structure 1 is finable with a volume of gas liquid as discussed above, a air/gas input port 8 is form in the outer flexible layer 2 of the compartment-defini structure 1. By attachment of a supply of gas or liquid --5 plaσed outside the body to the gas/liquid port 8 illustrated in Fig. 5B, the chamber 4 defined between t outer and inner flexible layers 2 and 3, can be filled wi gas or liquid so that the inner flexible layer 3 expan inwardly towards the liver. In Fig. 5C, the function of t

20 flexible expandable chamber 4 is clearly illustrated. F example, when the volume of gas or liquid is introduced in chamber 4, the inner flexible layer 3 expands inwardly towa the "Liver" so as to apply a distribution of pressure to t surface thereof. In this expanded volumetric state, t

25 expanded .flexible chamber 4 is denoted by 4* and t flexible inner layer is denoted by 3 • .

In order that the apparatus shown in Figs 5A and 5B capable of draining shedded blood collected within t compartment or space defined by the flexible compartmen

30 defining structure 1, a blood drainage port 9 is form through the outer flexible layer 2 and inner flexible layer of the compartment-defining structure 1 so as to be in flu communication with the volumetric-space defined by the inn surface of the flexible layer 3. As will be discuss 35 hereinafter, shedded blood collected within from t apparatus l of the present invention can be provided autotransfusion apparatus located outside the body f processing and subsequent reinfusion to the patient.

Referring now to Figs. 6A and 6B, an alternati embodiment of apparatus for compartmentalizing an intern bodily organ of a patient, is shown.

In Fig. 6A, in particular, a compartment-defini structure 1' for compartmentalizing a liver is shown in pl view with compartment-defining structure including a pair zipper members 10A' and 10A and 10B¹ and 10B, provided the perimeter edges of the compartment-defining structure and shown disposed in their unzippered "open" state. Th zipper members function as sealing means for bring together and providing a liquid seal to the perimeter e portions when the compartment-defining structure l¹ configured so as to surround and compartmentalize substantial portion of the organ. As illustrated in Figs. and 6B, the compartment-defining structure l¹ has physi dimensions sufficient to generally conform to the gr geometry of a substantial portion of the liver, i.e. when zipper members lOA'/lOA and lOB'/luB are zippered up, shown in Fig. 6B. The principal requirement of such zip members are that they provide a blood-tight seal, and do pinch or cut the external surface of the organs. Along the perimeter edges of the compartment-defin structure l¹ shown in Fig. 6A, there are portions D'and D the perimeter edges which are not provided with zip members, in order to form an opening 5' when the zippers zippered up and the compartment-defining structure configured so as to surround and compartmentalize the li as shown in Fig. 6B.

As illustrated in Fig. 6A, on the inside surface 11 the open compartment-defining structure 1", there provided a flexible expandable receptacle means realized the preferred embodiment, in the form of a symmetrical patterned arrangement 12 (i.e. expandable bladder or chambe comprising a network of expandable chambers, the resulta geometry of which appears similar to the lines on butterfly's wing. This network of flexible expandab chambers 12 has one input port 13 formed on the outside the flexible compartment-defining structure 1' and feeds t network of chambers with either a fluid (i.e. a liquid gas) supplied under pressure, in order to cause the flexib expandable chambers 12 to^' expand when the compartmen defining structure 1^» is configured to surround the live As a result of the expansion, a distribution of pressure applied to the external surface of the liver, in order achieve hemostasis thereof. As with the embodime illustrated in Figs. 5A, 5B and 5C, this particul embodiment also has an "output-port" since the flexib expandable chamber 12 is a closed circuit of air/liqu bladders, which is necessary to achieve expansion upon t introduction of a volume of liquid or gas into the network expandable chambers.

The configuration of flexible expandable chambers shown in 6A, is symmetric in order to produce a predetermin pressure pattern upon the external surface of the live However, the configuration of the flexible expandab receptacle means 12 hereof, can vary in shape and geomet without departing from the scope and spirit of the prese invention_*

The construction of the embodiment shown in Figs. and 6B, differs in several ways from the embodiment shown

Figs. 5A, 5B and 5C. In particular, the apparatus shown

Figs. 6A and 6B does not comprise an inner and outer la per se, but rather has an outer flexible layer 11 made o substantially non-elastic material impervious to gas liquid. Such a material can be for example, reinfor

Silastic R brand material, however, other functiona equivalent materials, for example, having biodegrada properties, can expectedly be used as well.

To form the flexible expandable chamber 12 (i.e. flexible expandable receptacle means hereof) disposed on inside surface of flexible layer 11 shown in Fig. 6A, one several possible techniques can expectedly be used. example, a network of preformed expandable inflata chambers having the geometry shown in Figs. 6A, can attached to the inside of flexible layer 11, using adhesive, ultrasonic welding or heat stamp welding, all kn in the art. With a hole 14 formed in the flexible layer input port 13 can be attached to an access opening of flexible expandable chamber network 12.

As illustrated in Fig. 6B, when the flexi compartment defining structure is applied about a mobili liver by surrounding the same and zippering up the seal members 10A^»/10A and lOB'/lOB, then a "blood-tig compartment is formed about the liver as desired. Thus, u introduction of a volume of gas or liquid at the input p

13, the flexible expandable chamber 12 expands and ther applies a predetermined distribution of pressure to external surface of the liver, to achieve hemostas

Notably, as in the embodiment of Figs. 6A and 6B, a shed blood drain port 16 can be provided through a hole 15 fo in one or more of the walls of the compartment-defi structure 1' for draining shedded blood collected ther and passing the same through the abdominal wall to autotransfusion or like device positioned outside the for the purposes of further collecting and processing shedded blood from the liver, and subsequent reinfusion the patient.

While the embodiments of Figs. 6A and 6B include use of zipper members lOA'/l-A and lOB'/lOB which together the perimeter edges of the flexible compartm defining structure of the present invention, function equivalent sealing means can expectedly be used as wel

However, regardless of whether or not plastic zipper membe or other fastening and sealing means are used for th purpose, a blood-tight seal should be formed at the perimet edges of the compartment-defining structure, so that shedd ^~ blood from the traumatized organ can be adequately collect as desired, while hemostasis is being carried out by t introduction of pressurized air or liquid to the network flexible expandable chamber 12.

Referring now to Figs. 7A, 7B and 7C in particula 0 another embodiment of the apparatus of the present inventi is shown. In Fig. 7A, the flexible compartment-defini structure 1^• * has disposed on its inner surface 18, t flexible expandable receptacle means hereof realized in t form of a continuous, flexible and expandable chamber form

^~-5 over a substantial portion of the inner surface 18 structure 1' ' . Over the inner surface 18 of t compartment-defining structure l'^», a plurality of space apart^*circular zones are formed, which are not finable wi air or liquid in order to produce a "button-in-a-pill

20 effect". Thi.s particular feature is particular advantageous in that it provides channels for the free f of shedded blood between the external surface of the or and inner surface of apparatus 1'', to drain and subsequen be collected for autotransfusion.

25 One manner in which this embodiment of the flexi expandable receptacle means hereof is formed, is by apply a flexible expandable resilient layer of material 20 o the flexible non-expandable outer layer 19 of compartment-defining structure 1' • , and to hermetically s

30 the flexible expandable layer 20 to the non-expandable la 19, at locations indicated by dotted lines shown in Fig. Notably, these locations are along the perimeter outlines the circular patterns 21 and the flexible compartme defining structure l^»'. This hermetic sealing operation 35 results in the formation of a continuous flexible gas/liqu chamber 23 illustrated in Fig. 7C. This chamber is finab from an input port 22 which has fluid access to the interi of the flexible expandable chamber 23 through the re portion of the flexible compartment-defining structure 1' similar to the embodiment disclosed in Fig. 6A and 6B.

As a volume of gas or liquid is provided to the inp port 22, the space 4 between the inner flexible expandab layer 20 and the outer flexible non-expandable layer 1 fills with air or liquid (as the case may be) and causes flexible expandable inner layer 20 to expand as illustra in Fig. 7C. This expansion, in turn, causes a decrease the volume formed between the inner and outer surfaces of t compartment-defining structure, i.e. when configured so to surround and compartmentalize a liver as shown in Fig. 7 Consequently, the expansion of the flexible expanda chamber 23 causes a pressure distribution to be applied the traumatized organ compartmentalized within compartme defining structure 1'', so as to achieve hemostasis ther in a manner which will be discussed in greater detail her below. In order to collect shedded blood, blood drain port 25 is provided in a manner described in the embodim of Figs. 7A and 7B.

Referring now to Figs. 8A and 8B, another embodiment the apparatus for containing a traumatized liver, is sho In Fig. 8, the outer surface of the flexible compartme defining structure l''¹ is shown disposed in two dimensio with zipper members lOA'/lOA and 10B'/10B engaged in th "open" state. Notably, the overall geometry of the flexi compartment-defining structure l'¹' is substantially simi to the embodiments illustrated in Figs. 5A/5B, 6A/6B 7A/7B. On the outside surface 26 of the flexi compartment-defining structure l''¹, a flexible flu containable receptacle means is disposed over a substant portion thereof and is capable of containing a volume liquid or gas to be passed or otherwise circula therethrough, for heat exchange purposes to be discussed greater detail hereinbelow.

As shown in the embodiment of Figs. 8A and 8B, t flexible fluid-containable receptacle means hereof realized in the form of a gas/fluid-carrying tubular netwo 5

27 having an input port 28 and an output port 29 for t introduction and removal of a liquid or a gas, respectivel Between the input and the output ports 28 and respectively, a liquid or gas can be passed through t tubular network 27 so as to transfer heat away from (or t 0 an organ which is being surrounded by the compartmen defining structure 1''' bearing the flexible tubular netwo 27 on its outer surface 26, as shown in Fig. 8B. addition, a blood drainage port 29 can also be provided the flexible compartment-defining structure 1• ' * for t 5 collection of shedded blood from the traumatized organ duri a surgical procedure, utilizing the apparatus shown in Fi 8A.

^"As illustrated in Fig. 8B, a fluid circulation mean such as a pump 30, is provided to a circuit comprising 0 supply of liquid or gas 31 connected in fluid communicati with the flexible expandable tubular network 27. The pu 30 provides for the circulation of the liquid or gas throu the flexible tubular network 27 in order to achieve he exchange between the liquid or gas and the organ. 5 maintain the temperature of gas or liquid, a temperatu control means 32, e.g. heat exchanger, is connected with the fluid circuit of Fig. 8B.

As is apparent from Fig. 8B, a liver surrounded by a compartmentalized within the flexible compartment- defini structure 1' ' ' , bearing the flexible fluid-containab tubular network 27, is most suitable for manipulating temperature of a traumatized organ during a particul surgical procedure or during organ procurement a implantation. A method of using such apparatus shown

-^>-⁾ Figs. 8A and 8B, will be discussed in greater det hereinbelow.

Turning now to Fig. 9, a preferred embodiment of t apparatus of the present invention is shown, in which all the features of the present invention illustrated in Fig

5A, 5B, 6A, 6B, 7A, 7B, 8A and 8B are integrated into o ^~ system capable of carrying out several functions.

In Fig. 9, yet another embodiment of the flexib compartment-defining structure ι***^» is shown, configured as to surround and compartmentalize a traumatized liver (n shown) . This embodiment of the flexible compartmen 0 defining structure hereof incorporates the inventive featur of the embodiments disclosed in Figs. 5A/5B, 6A/6B, 7A/7 and Fig. 8A/8B. Specifically, the flexible compartmen defining structure 1• ' * has disposed over a substanti portion of its inner surface, the flexible expandab -^■-> receptacle means hereof (not shown) which can be any one the embodiments illustrated in Figs. 5A/5B, 6A/6B or 7A/7 On the outer surface of the flexible compartment-defini structure l¹''', there is disposed the flexible flui containable receptacle means (i.e. tubular network) of t

20 form illustrated in Figs. 8A and 8B, for example.

The input and output ports 28 and 29 respectively this embodiment of apparatus for organ compartmentalizati are connected to respective ports of an organ surfa temperature control system 35. In general, the or ²5 surface-temperature control system 35 comprises: the sup of liquid or gas 31 connected in fluid communication with flexible fluid-containable receptacle means (i.e. flexi tubular network) 27; the pump 30 for circulating the liq or gas through the flexible tubular network 27; and

30 temperature control means 32 for controlling the temperat of the fluid or gas being circulated through the flexi tubular network 27. In one embodiment of the pres invention, the fluid to be passed through the flexi tubular network 27 is a non-toxic heat exchanging liquid

35 gas. In order to detect the organ surface-temperature various locations on the organ, a network of spaced-apa temperature sensors (indicated by triangles ___ on surface 2 are mounted through the walls of the flexible compartmen defining structure 1''', for example, between the tubul 5 passage ways 27, and within the hermetically sealed circul patches 21 as shown in Fig. 7A. The temperature-sensors c be realized as heat-sensitive crystal devices install through the walls at 21, in a liquid-tight manner. Ea sensor is connected to appropriate instrumentation circuit 0 (not shown) , known in the art. The temperature-sensors ser the function of detecting a plurality of organ surfac temperature values 36, which are converted in numerical fo for monitoring purposes, in a manner known in the biomedic instrumentation arts. 5 In order to collect shedded blood from the traumatiz organ during, for example, a surgical operation, the blo drainage port 29 formed through the compartment-defini structure 1' * ' , is maintained in fluid communication with blood collection and processing system 40, also known in t 0 art for collecting and processing blood for reintroduction the patient's circulatory system, by principles of aut transfusion.

In order to carry out hemostasis of a traumatized org which is massively bleeding, the input port 22 of t 5 flexible expandable chamber 27 is connected in flui communication with an organ surface-pressure supply control system 50 as illustrated in Fig. 9. The or surface-pressure supply and control system 50 typical includes a supply of gas or liquid 51 as in Fig. 6A 0 introduction under pressure into the expandable chambers the expandable receptacle means 27 hereof. However, in or to maintain a constant supply of pressure, a pump functionally equivalent means (e.g. hand-squeezable air-b and tubing 73 as illustrated in 5B) can alternatively

" -^,5 provided for introducing gas or liquid into the flexi expandable receptacle means hereof, and maintaining t introduced volume of gas or liquid at a predetermin pressure.

In order to determine an appropriate level of pressu for carrying out hemostasis, (i.e. a stoppage of shedd blood from a traumatized organ) , the shedded blood collect from the compartment-defining structure l' ' ' ' is monitored the blood collection and processing system 40. On the bas of the monitored shedded blood flow rate and the org surface-pressure signals, the amount of pressure necessary achieve the hemostasis is determined. In order to produ such organ surface-pressure signals, pressure transducers a provided to the surfaces of the expandable chambers here shown for example in Figs. 5A, 5B, 6A, 6B, 7A, and 7B. T preferred embodiment, piezo-electric-type pressu transducers are molded into the walls of the expandab chambers 27.

In order that a health care professional using t apparatus of the present invention, can easily ascerta information regarding the surface-pressure and surfac temperature of the organ while compartmentalized by t flexible compartment defining structure hereof, the appara shown in Fig. 9 further includes a three dimensional (3 organ modelling means 60, a visual display 65, and keyboard/control means, connected in a manner known in computer-graphic modelling art. The 3-D organ modell means 65 is provided for generating a computer-genera model of the organ and providing the same in real-time to visual display means 65 for visually displaying (i) modelled organ, (ii) detected organ surface-temperatur and (iii) surface-pressures shedded blood flow rates.

In the preferred embodiment, the 3D organ modell means 60, visual display means 65, and keyboard/control me 70 is realized in the form of a 3D computer graphic w station 59 having 3D surface and solid modell capabilities. Detected organ surface-temperature signa organ surface-pressure signals and shedded blood flow rate are provided to the 3D computer graphic work station 59 f display on respective portions of the 3D solid or surfa model of the organ being modeled and visually displayed on

CRT display screen 65.

Thus, wi.th the work stati.on 59 a health profession can easily ascertain vital information regarding the state a traumatized organ, and through the use of a us control/interface activatable through conventional keyboa

70 or other interface device of the work station 59, vario organ surface-^pressures and surface-temperatures can programmably controlled and monitored in accordance with t principals of the present invention.

Referring now to Figs. 1A, IB, 1C, 2, 3 and 4, particular, a present method of compartmentalizing internal bodily organ of a patient which is massive bleeding, will now be described hereinbelow, in connecti with the apparatus shown in Figs. 5A and 5B.

. ^"Prior to compartmentalizing a massively bleeding liv in accordance with the present invention, the method of t present invention involves first mobilizing the liver order to render a substantial portion thereto capable being surrounded by the flexible-compartment defini structure shown for example, in Figs. 5A/5B, Figs. 6A/6B

Figs. 7A/7B and described in great detail hereinabove.

In general. Figs. 1A, IB and 1C show the position the liver within the peritoneal cavity of a human patie

Notably, in Fig. 2, the liver is clearly shown to be bel the diaphragm and as illustrated in Fig. 3, the l triangular ligament, right triangular ligament, coron ligament and falciform ligament must be severed, so as expose a major portion of the bare area of the diaphragm freeing the liver from a large part of its attachments the diaphragm and other peritoneal structures.

In a manner known to the medical profession, relationship of the liver to the "portal triad", the g bladder and inferior cava and hepatic veins will be le intact in their anatomical locations. Thus, by carrying su a procedure, a substantial portion of the liver will mobilized and exposed without interfering with the vit functions of the liver and the remaining portions of t ^~ ^ body.

After mobilizing the liver as described above, substantial portion of the mobilized organ is surrounded wi the flexible compartment-defining structure so as compartmentalize a substantial portion thereof. Up 0 compartmentalizing the organ, the portal triad and inferi vena cava of the liver is allowed to project from the openi 5 formed in the flexible compartment-defining structu hereof, while the remaining surface area of the liver and t gall bladder is embraced by and compartmentalized within t -^~5 flexible compartment-defining structure, akin to a jack around the person's torso.

Upon compartmentalizing the liver, as described abov a volume of air or fluid is introduced into the input port of the embodiment shown in Figs. 5A/5B, for example, so

20 to cause the expandable receptacle means (i.e. expandab bladder or chamber 4) to inflate, expand and thereby apply pressure distribution upon the external surface of t massively bleeding liver. This expansion can be achieved example, by simply connecting a tube 71 and hand-held

25 bulb assembly 72 to input port 8 and squeezing the bulb fill the expandable chamber 4 with air, or the m complicated pressure supply and control system 50 disclo in Fig. 9, can be used as well. This volume-expansion eff of the expandable chamber 4, as described hereinbefo

30 applies pressure to the liver which, in turn, tamponades bleeding. Also, shedded blood from the massively bleed liver is collectable within the blood-tight compartme defining structure 1 and can be allowed to exit through drainage port 9 for collection and processing by 35 autotransfusion apparatus 40, illustrated in Fig. 9 particular.

In order to determine the amount of pressure require to achieve full hemostasis of a massively bleeding liver, conventional in-line type pressure gauge can be inserte along tubing 71 as illustrated in Fig. 5B, in order to obtai a reliable measure of the amount of surface pressure bein applied to the bleeding organ.

Having applied a flexible compartment-definin structure hereof to an organ of a patient, several possibl options are available to the health professional regardin how the apparatus is to be .disposed. In each case, however the options available depend on the particular embodiment o the compartment-defining apparatus hereof utilized, as wel as the clinical status of the patient.

For example, using the apparatus illustrated in Figs

5A, 5B and 5C, the flexible expandable chamber 4 having bee pressurized with sufficient volume of gas or liquid t achieve hemostasis, can be sealed off, for example, b clamping or otherwise hermetically occluding the gas/liqui port 8, using mechanical occluding devices, valves o functionally equivalent means. Regarding tubing attached t shedded-blood drainage port 9, an opening in the anterio abdominal wall of a patient can be formed so as to allow t tubing to be connected to an autotransfusion means 40, shown in Fig. 9, so as to allow for monitoring of shedd blood, processing thereof and subsequent reinfusion into t patient, as described hereinbefore.

In the embodiment shown in Fig. 5B, a tube 7 connected to gas/liquid port 8 can be allowed to pass throu the opening in the anterior abdominal wall of patient, a using a pressure gauge or meter inserted, for example, in t line of tubing 71, the health professional can (from outsi of the body) increase or decrease (i.e. manipulate) t surface pressure applied to the organ, as he or she dee necessary in view of clinical status of the patient and t monitored conditions of shedded blood being collected. The compartment-defining jacket-like apparatus here would be left in place in the body with pressure manipulati set as needed. The apparatus is then removed by anot surgical procedure upon the discretion of the health c providers.

In the embodiment shown in Figs. 8A and 8B, flexible fluid-containing receptacle means 27 can be used maintain the surface-temperature of an organ, such as liver, during a liver transplant, with the provision of organ surface-temperature control system shown in Fig. 9, example. Notably, with the to-be transferred li compartmentalized within the flexible compartment-defin structure 1''' the surface temperature of the liver can controlled in a required manner known in liv transplantation art. Preferably, the nature of the liquid gas to be passed through the flexible tubular network should have physical properties sufficient to achi cooling, while not being toxic to the patient in the event inadvertent leakage as by accident.

Having described hereinabove the various aspects of present invention with respect to the liver, seve alternative embodiments of the present invention come to m with respect to application of the present invention other organs are now apparent.

For example, referring to Figs. 10A, 10B, 11A, 11B, and 12B m particular, the compartment-defining apparatus the present invention is shown adapted for application to spleen, kidney, and uterus, respectively. In each s embodiment, the physical dimensions of the flexi compartment-defining structure l, are tailored so as generally conform to the gross geometry of a substant portion of the respective organ. As with the embodime described with respect to the liver, the flexi compartment-defining structure for the spleen, kidney uterus have also an inner surface and an outer surface, is configurable so as to surround and compartmentaliz substantial portion of the spleen, kidney, and uterus, illustrated in Figs. 10B, 11B, and 12B, respectively.

However, in applying each of the organ-adapt compartment-defining apparatus illustrated in Figs. 10

11B, and 12B, each organ requires that different surgic - ^J organ-mobilization procedures be carried out prior to t application of the compartment-defining apparatus hereof its respective organ.

For example, the spleen can be mobilized by incisi its anatomical attachments to the peritoneum, diaphrag 0 kidney, greater omentum, colon and stomach using a techniq known in the surgical arts. After mobilization, the sple is detached from the body except for its medial attachme to the splenic pedicle (i.e. artery and vein) and to t pancreas, thus rendering a substantial portion there 5 capable of being surrounded by the flexible compartmen defining structure shown for example, in Fig. 10B.

In a similar fashion, a traumatized bleeding kidn would"be mobilized by incising the surrounding peritoneum a Gerota's Fascia, thus detaching it from the posteri 0 abdominal wall and adrenal gland, leaving its anatomic attachment to the renal artery, vein, pelvis and uret intact, and thus rendering a substantial portion there capable of being surrounded by the flexible compartmen defining structure, shown, for example, in Fig. 11B. 5 In a similar fashion, the method and apparatus of t present invention may be applied to a uterus which internally bleeding due to post partum, post-operative other pathological processes, and not responding conventional therapy. In this particular embodiment, t

30 uterus is mobilized by retracting the uterus anteriorly a severing any attachments to the sig oid, colon, urina bladder, without intervening with the blood supply to organ, or the attachments of the fallopian tubes, t rendering the peritoneal portion of the uterus capable

35 being surrounded by and compartmentalized within the flexi compartment-defining structure as illustrated, for exampl in Fig. 12B.

While the particular embodiments shown and describ above are useful in many applications involving the surgic arts, further modification of the present invention here disclosed will occur to those skilled in the art to which t present invention pertains and all such modifications a deemed within the scope and spirit of the present inventi defined by the following claims.

Claims

WHAT IS CLAIMED IS:

1. Apparatus for partially surrounding an intern bodily organ of a patient, said apparatus comprising: a flexible compartment-defining structure havi physical dimensions sufficient to generally conform to t gross geometry of a substantial portion of said organ, said flexible compartment-defining structu further having an inner surface and an outer surface, a being configurable so as to surround and compartmentalize substantial portion of said organ, with said inner surfa facing the external surface of said organ.

2. The apparatus of Claim 1, which further comprises a flexible expandable receptacle means dispos 5 ^J over a substantial portion of said inner surface and bei positionable between said flexible compartment-defini structure and said organ, said flexible expandable receptacle means bei capable of containing a volume of gas or liquid for apply 0 a distribution of pressure to said external surface of s organ while a substantial portion of said organ is surroun by and compartmentalized in said flexible compartme defining structure generally conforming to the gross geome of said organ. 5

3. The apparatus of Claim 1, wherein said flexi compartment-defining structure is made of a material which impervious to blood.

0 4. The apparatus of claim 3, wherein said material a substantially non-stretchable and gas/liquid non-permea material.

5 5. The apparatus of Claim 3, wherein said flexib compartment-defining structure has at least one port form therein, for the drainage of shedded blood collected with the compartment formed by said flexible-compartment-defini structure surrounding said organ.

6. The apparatus of claim 5, wherein said port furth includes a connection means for connecting a tube to sa port.

7. The apparatus of claim 5, which further compris auto transfusion means to which said tube is connected on o end thereof and the other end of said tube is connected said port, said auto transfusion means including a bl collection means for collecting and storing blood recei -¹ from said tube, and a blood processing means for receiv blood from said blood collection means and for process said blood for reintroduction into said patient.

8. The apparatus of claim 2, wherein said flexi 0 compartment-defining structure comprises: an outer flexible layer made of a substantia non-elastic material impervious to gas or liquid, and hav physical dimensions sufficient to generally conform to gross geometry of said organ, and 5 an inner flexible layer made of a mater impervious to gas or liquid, and having physical dimensi sufficient to generally conform to the gross geometry of s organ, said inner flexible layer being hermetically sea to said outer flexible layer at overlapping adjac 0 portions thereof, so as to form said flexible expanda receptacle means, and said inner flexible layer forming s inner surface of said flexible compartment-defining struct and said outer flexible layer forming said outer surface said flexible compartment-defining structure.

35

9. The apparatus of claim 8, wherein said inner a outer flexible layers are hermetically sealed at overlappi adjacent portions thereof and in accordance with a pattern configuration so as to form said flexible expandab receptacle means.

10. The apparatus of claim 9, wherein said pattern configuration comprises a plurality of spaced apart circle all of which are enclosed by a boundary adjacent t perimeter of said layers, so as to thereby form a chamb between a substantial portion of said flexible layers, whi is capable of being filled with a volume of a gas or liquid

11. The apparatus of claim 2, wherein said flexib expandable chamber disposed over a substantial portion said inner surface and capable of containing a volume of g or liquid for applying a distribution of pressure to sa external surface of said organ while a substantial portion said 'organ is surrounded by and compartmentalized in sa flexible compartment-defining structure generally conformi to the gross geometry of said organ.

12. The apparatus of claim 1, wherein said flexib compartment-defining structure has physical dimensio sufficient to generally conform to the gross geometry of substantial portion of an organ selected from the gro consisting of the liver, the spleen, the uterus and kidney.

13. The apparatus of claim 8, which further compris a sealing means for bringing together and liquidica sealing perimeter portions of said hermetically sealed in and outer layers, when said flexible compartment-defin structure is configured so as to surround a compartmentalize a substantial portion of said organ. -35-

14. Apparatus of claim 1, which further comprises sealing means for bringing together and sealing perimet portions of said flexible compartment-defining structur while being configured so as to surround and compartmentali a substantial portion of said organ.

15. Apparatus of claim 2 which further comprises an inlet means connected with said flexib expandable receptacle means, for filling said flexib expandable receptacle means with a gas or liquid, and a supply of gas or liquid in fluid communication wi said flexible expandable receptacle means, said supp capable of filling said flexible expandable receptacle mea with a volume of said gas or liquid so as to cause sa expandable receptacle means to expand while said flexib 5 ^■J compartment-defining structure is configured to surround a compartmentalize said substantial portion of said organ, a thereby apply said distribution of pressure to said organ.

16. Apparatus of Claim 15, which further comprises: 0 at least one surface sensing means disposed said inner surface of said flexible compartment-defini structure, for sensing the surface-pressure being applied a predetermined portion of said organ, register means for registering said predetermi ^J5 surface-pressure value of said organ, control means for controlling the pressure of s supply of gas or liquid, in response to a pressure-adjustm signal, and comparing means for comparing said measu 0 surface-pressure with said predetermined surface-pressure producing a pressure adjustment signal in response to s comparison.

17. Apparatus of claim 16, which further comprises

35 a plurality of surface-pressure sensing me disposed at spaced-apart locations on said inner surface o said compartment-defining structure, and display means for displaying the said measure surface pressures.

5 ^J 18. The apparatus of claim 17, which further comprise

3-D organ modelling means for modelling sai organ, and for providing said sensed surface-pressure value on corresponding locations of said organ, and wherein said display means comprises a visua 0 display means for displaying said model of said organ alo with said sensed surface-pressure values.

19. The apparatus of claim 1, which furth comprises

-¹ a flexible fluid-containable receptacle mea disposed over a substantial portion of said flexib compartment-defining structure, and capable of containing fluid or gas, to be passed therethrough.

0 20. The apparatus of claim 19, which furth comprises a supply of liquid or gas in fluid communicati with said flexible fluid-containable receptacle means, circulation means for circulating said liquid -* gas through said flexible fluid-containable receptacle mean and temperature control means for controlling t temperature of said fluid or gas being circulated throu said flexible fluid-containable receptacle means. 30

21. The apparatus of claim 20, which furth comprises a plurality of surface-temperature sensing mea 3 disposed on said flexible compartment-defining structure f sensing the surface-temperature of said organ surrounded and compartmentalized with said flexible compartment-defini structure, . and wherein said temperature-control means is capab of programmably controlling the temperature of said gas . . liquid in response to said sensed surface-temperature said organ by said surface-temperature sensing means.

22. The apparatus of claim 20, which furth comprises a monitoring means for monitoring sens surface-temperature of said organ, and for displaying s surface-temperatures on a display means.

23. A method for compartmentalizing an internal bod 5 ^•* organ of a patient which is massively bleeding, said met comprising the steps of

(a) providing a flexible compartment-defin structure having physical dimensions sufficient to genera conform to the gross geometry of a substantial portion 0 said organ, and being configurable so as to surround compartmentalize a substantial portion of said organ;

(b) during a surgical operation upon said pati having a massively bleeding organ, mobilizing said organ as to render a substantial portion of said organ capable 5 being surrounded by said flexible compartment-defining structure; and

(c) surrounding a substantial portion of s mobilized organ with said flexible compartment-defin structure so as to compartmentalize said substantial port 0 of said mobilized organ.

24. The method of claim 23, wherein step comprises mobilizing a human liver so as to render substantial portion of said liver capable of being partia 5 surrounded by said flexible compartment-defining structure

25. The method of claim 24 wherein said mobilizi step includes severing the left triangular ligament, rig triangular ligament, the coronary ligaments, and t falciform ligament, so as to substantially detach said liv from the diaphragm, of said patient and mobilize said org for being surrounded and compartmentalized by said flexib compartment-defining structure.

26. The method of claim 24 wherein said mobiliz liver is hermetically compartmentalized for the purpose achieving hemostasis through a tamponade effect.

27. The method of claim 23, wherein step (b) compris mobilizing a human spleen so as to render a substanti portion of said spleen capable of being partially surround by said flexible compartment-defining structure.

28. The method of claim 27, wherein said mobilizi step includes severing the attachments of said spleen to t surrounding abdominal structures, except for the hili structures which include the splenic arteries and veins a the tail of the pancreas.

29. The method of claim 27, wherein said mobiliz spleen is hermetically compartmentalized for the purpose achieving hemostasis through a tamponade effect.

30. The method of claim 23, wherein step (b) compris mobilizing a human kidney so as to render a substanti portion of said kidney capable of being partially surround by said flexible compartment-defining structure.

31. The method of claim 30, wherein said mobilizi step includes severing the attachments of said kidney to th surrounding abdominal structures, except for the hila structures which include renal arteries, veins, the rena pelvis and the ureter.

32. The method of claim 31, wherein said mobilize kidney is hermetically compartmentalized for the purpose o achieving hemostasis through a tamponade effect.

33. The method of claim 23, wherein step (b comprises mobilizing a human uterus so as to render substantial portion of said uterus capable of being partiall surrounded by said flexible compartment-defining structure.

~^* 34. The method of claim 33, wherein said mobilizin step includes severing the attachments of said uterus to th surrounding peritoneal structures, except for the fallopia tubes and the uterine vasculature. 0

35. The method of claim 34, wherein said mobilize uterus is hermetically compartmentalized for the purpose achieving hemostasis through a tamponade effect.

5 36. Apparatus for surrounding an internal bodi organ, to arrest said organ from massively bleeding, sa apparatus comprises an outer flexible layer made of a substantial non-elastic material impervious to gas or liquid, and havi 0 physical dimensions sufficient to generally conform to t gross geometry of the internal bodily organ, an inner flexible layer made of a materi impervious to gas or liquid, and having physical dimensio sufficient to generally conform to the gross geometry of t 35 internal bodily organ, said inner flexible layer being positioned aroun said outer flexible layer and hermetically sealed a perimeter edges thereof so as to form a jacket-like assembl having a hermetically sealed chamber between said oute flexible layer and said inner flexible layer, and compart e nt substantially conforming to the gross geometr of said internal bodily organ, said chamber to be filled wit a pressurized gas or liquid which causes said inner flexibl layer to expand and distribute the pressure of said gas o liquid to said internal bodily organ; and sealing means for maintaining said adjoinin edges relatively fixed while said chamber is filled with sai pressurized gas or liquid.