RU2792566C1 - Device for sampling subcutaneous adipose tissue in patients with extensive skin burns - Google Patents

Abstract

FIELD: medicine; medical equipment.

SUBSTANCE: invention relates to medical equipment and can be used as a counter stop for a syringe in order to create and maintain negative pressure necessary for taking adipose tissue in undamaged areas of the body of limited area in patients with burns. A device for sampling subcutaneous adipose tissue in patients with extensive skin burns consists of two semi-cylindrical parts with a semi-cylindrical protrusion from the proximal end for fixation in a medical drill chuck, which are assembled into a single cylindrical structure by tongue-and-groove joints. One part — a hollow semi-cylinder — contains a one-way intra-lock mechanism, represented by four stops-teeth, the maximum distance from the inner surface of the half-cylinder to the edge of the stop-tooth is 30–35% of the diameter of the syringe rod stop. On the cross section through the axis of the cylinder, the distal side of the stops-teeth has a slope of 35°, and the proximal side of the teeth stops has a slope of 90°. On the distal base in the middle along the axis of the cylinder, a longitudinal open groove is made, corresponding in depth to 50% of the width of the syringe rod. On teeth-stops, open grooves are made so that their lower level corresponds to the lower level of the base groove. The other part of the device is a solid semi-cylinder, corresponding in its size to the first semi-cylinder and containing transverse grooves on the inner surface, arranged so that the distal edge of each groove corresponds to the edge of each stop-tooth. The depth of the groove is 30–35% of the diameter of the stop of the syringe rod. A longitudinal open groove is made in the middle along the axis of the cylinder, corresponding in its depth to 50% of the width of the syringe rod.

EFFECT: reduction of the risk of perforation of the underlying tissues with cannulas and infectious complications in the area of adipose tissue sampling in patients with extensive skin burns by replacing the reciprocating movements of the cannula from outside to inside and back to rotational movements.

1 cl, 5 dwg

Description

SUBSTANCE: invention relates to medicine, medical equipment and can be used as a counter stop for a syringe in order to create and maintain negative pressure necessary for taking adipose tissue in undamaged areas of the body of limited area in patients with burns.

The collection of adipose tissue by vacuum aspiration is one of the most widely used surgical procedures in the world [1]. In the largest proportion of cases, subcutaneous adipose tissue is taken in order to remove it (liposuction) or move it to areas with tissue deficiency (lipofilling). In addition to aesthetic surgery, adipose tissue sampling is used in the fields of regenerative medicine, where low-manipulative adipose tissue products are used to stimulate the healing of wounds of various origins, incl. burn. The overall incidence of local complications after adipose tissue sampling is in the range of 8.6-20%. The most severe consequences are caused by complications caused by infection of the subcutaneous tissue, perforation of the fascial-muscular layer of the abdominal wall, and adjacent organs of the abdominal cavity. Clinically, infectious complications of mild and moderate severity are manifested in the early stages of the postoperative period by deformity, local inflammation (20%), seroma (2.3–3.5%), and in the long-term period by hyperpigmentation, asymmetry, and the formation of a hypertrophic scar [2].

Severe (even fatal) complications, such as injury to the abdominal organs and abdominal wall, hematoma with active bleeding, skin necrosis, infection, necrotizing fasciitis, pulmonary embolism, are recorded in 0.02-0.25% of cases after subcutaneous tissue sampling [ 3-5]. The most frequent severe complications are necrotizing fasciitis, gas gangrene, various forms of sepsis [7]. Considering the number of adipose tissue harvesting operations in the world, we are talking about several thousand severe postoperative complications per year [6]. Berger O. reported 27 cases of bacterial infection in the area of liposuction: necrotizing fasciitis was diagnosed in 14 cases, of which 9 patients eventually died [8]. Liu Z et al described a clinical case of symmetrical peripheral gangrene and necrotizing soft tissue infection of the buttocks followed by the development of sepsis in a 23-year-old female patient after aesthetic liposuction [9]. Beaudoin AL et al. described 4 clinical cases of necrotizing fasciitis, 1 of which ended in death [10]. Cuevas Bustos R. published a clinical example of a necrotizing soft tissue infection in the area of liposuction followed by the development of septic shock [11]. Four cases of skin necrosis and two cases of wound infection after adipose tissue sampling have been reported by Kim YH et al . [2].

Perforation of the abdominal or intestinal wall is the second most common cause of death after adipose tissue sampling [12]. Skorochod R. et al. a systematic review of the literature reported a total of 49 cases of visceral perforation after abdominal liposuction procedures, of which 7 cases were fatal [13]. Although the cannula is inserted into the subcutaneous layer of the abdominal wall, it can damage deeper structures such as abdominal wall muscles or even abdominal organs. As a rule, this is due to the fact that the cannula is inserted blindly without imaging control, at the wrong angle, as well as high-amplitude movements during the procedure. Damage to the abdominal muscles can lead to the formation of a hernia of the anterior abdominal wall. Damage to the intestinal wall during liposuction, in turn, can lead to peritonitis [14]. In this case, the most frequently damaged organ of the abdominal cavity is the small intestine, in rare cases, damage to the gallbladder, pancreas and spleen has been reported [7,15].

The set of instruments used for taking adipose tissue usually includes a cannula, a syringe, and devices that ensure the creation and maintenance of negative pressure in the lumen of the syringe. Special devices are being actively developed that allow mechanically holding the syringe plunger, adjusting the amount of negative pressure in the lumen of the syringe and cannula during the sampling of adipose tissue. They facilitate the performance of manipulations and, thereby, indirectly reduce the risk of infectious and traumatic complications. An important direction in reducing the risk of complications is the introduction of devices that allow the removal of adipose tissue without reciprocating cannula movements, but using rotational or pendulum movements [16]. The amplitude of movements of the terminal section of the cannula in the "blind zone" of the tissue is significantly reduced, which reduces the risk of damage to the underlying tissues during a biopsy of adipose tissue. However, the efficiency of rotational movements during adipose tissue sampling is significantly lower compared to the traditional reciprocating technique, which complicates the design of the cannula and its holes [16, 17].

Thus, despite the widespread procedure for the collection and transplantation of adipose tissue for cosmetic and therapeutic purposes, the tasks of minimizing the risk of local infectious and traumatic complications remain unresolved. It is especially important to solve these problems in groups of patients for whom adipose tissue sampling is performed for therapeutic purposes, primarily for the healing of extensive wounds. As a rule, areas of the skin and subcutaneous tissue where adipose tissue can be harvested are small in area in patients with extensive wounds, they are often localized in zones that are “uncomfortable” for manipulation, which increases the risk of damage to the underlying fascia during traditional reciprocating cannula movements.

A manipulator device for an injection syringe is known (RF Patent No. 115666, 2011), which makes it possible to fix the syringe plunger and thereby maintain negative pressure in the syringe lumen without additional effort during tissue sampling. The device contains a syringe body holder and an additional cylindrical counter-stop fixed on the outer surface of the syringe, and a pull lever mounted on the counter-stop, the syringe body holder is made with a gap for the syringe body, a handle, with two telescopic guide rods rigidly connected to the thrust bearing fixing the syringe rod. The device is used to create and maintain the necessary pressure in the lumen of the syringe during tissue aspiration, injection into the tissue.

The disadvantages of this device are:

- the possibility of performing only reciprocating movements during tissue aspiration, the lack of technical feasibility of the rotational movement of the syringe needle;

- high risk of fascia perforation during reciprocating movements of the cannula in patients with a small layer of subcutaneous adipose tissue and small areas of tissue undamaged by burns.

Known lock for the syringe used to fix the plunger of the syringe and create a negative pressure during lipoaspiration [Syringe Lock, GREATLN, China]. The device contains two plates rigidly fixed in the proximal section, one of which is straight, the other is curved, the ends of which diverge in the distal section due to elastic deformation. The device is used to create and maintain the necessary pressure in the lumen of the syringe during aspiration of adipose tissue during liposuction.

The disadvantages of this device are:

- the possibility of performing only reciprocating movements during tissue aspiration, the lack of technical feasibility of the rotational movement of the syringe needle,

- slipping of the curved plate into the lumen of the syringe.

The closest analogue of the proposed device is the PAC syringe holder for aspiration biopsy [RZN 2017/5967, OKP/OKPD: 32.5013.110, Sterylab, Italy], containing a clamp-lock with two guide rods rigidly connected to the support handle and a thrust bearing, fixing rod of the syringe; the thrust bearing has axial grooves for guide rods and an oval hole for gripping with two fingers.

The disadvantages of this device are:

- the possibility of performing only reciprocating movements during tissue aspiration, the lack of technical feasibility of the rotational movement of the syringe needle;

- high risk of fascia perforation during reciprocating movements of the cannula in patients with a small layer of subcutaneous adipose tissue and small areas of tissue undamaged by burns.

The objective of the invention is the creation of a device for sampling subcutaneous adipose tissue in patients with extensive skin burns, providing the possibility of performing both reciprocating and rotational movements in the subcutaneous tissue to reduce the risk of contact infection of adipose tissue and perforation of the underlying fascia in areas of tissue of a limited area with a shallow depth layer of subcutaneous tissue.

EFFECT: reducing the risk of perforation of the underlying tissues with cannulas and infectious complications in the area of adipose tissue sampling in patients with extensive skin burns due to the replacement of reciprocating movements of the cannula from outside to inside and back to rotational movements.

The technical result is achieved by a collapsible device of two parts of a semi-cylindrical shape and a semi-cylindrical protrusion from the proximal end for fixation in the chuck of a medical drill, which are assembled into a single cylindrical structure by means of tongue and groove joints, one part is a hollow semi-cylinder containing a one-way locking mechanism inside, represented by four stops-teeth, the maximum distance from the inner surface of the semi-cylinder to the edge of the stop-tooth is 30-35% of the diameter of the syringe rod stop, on the cross section through the axis of the cylinder, the distal side of the stops-teeth has a slope of 35°, and the proximal side of the stops-teeth has a slope 90°, on the distal base in the middle along the axis of the cylinder, a longitudinal open groove is made, corresponding in depth to 50% of the width of the syringe rod, open grooves are made on the teeth-stops so that their lower level corresponds to the lower level of the base groove; the other part of the device is a solid semi-cylinder, corresponding in size to the first semi-cylinder and containing five transverse grooves on the inner surface, arranged so that the distal edge of the four grooves corresponds to the edge of each stop-tooth, the groove depth is 30-35% of the diameter of the syringe rod stop, in the middle along axis of the cylinder, a longitudinal open groove is made, corresponding in depth to 50% of the width of the syringe rod.

The device is illustrated by graphic materials, where:

in fig. 1 photo of the assembled device; in fig. 2 disassembled photos of the device; in fig. 3 - photograph of the counter stop assembly, the stop of the syringe rod is fixed in the 1st position; in fig. 4 - photograph of the counter stop assembly, the stop of the syringe rod is fixed in the 2nd position; in fig. 5 - photo of the counter stop assembly, the stop of the syringe rod is fixed in the 4th position, the device is assembled and installed in a medical drill.

The device consists of two semi-cylindrical parts with bases and a semi-cylindrical protrusion at the proximal end for fixation in the cartridge of a medical drill, which are assembled into a single cylindrical structure by means of tenon-groove joints (Fig. 1). One part is a hollow half-cylinder containing inside the one-way locking mechanism, represented by four stops-teeth. The edge of the stop-tooth (Fig. 2, 1) is a chord parallel to the diameter of the half-cylinder. The maximum distance from the inner surface of the semi-cylinder to the edge of the stop-tooth is 30-35% of the diameter of the stop of the syringe rod. At the same time, on the cross section through the axis of the cylinder, the distal side of the stops-teeth has a slope of 35°, and the proximal side of the stops-teeth has a slope of 90°. From the proximal end of the device, a thorn/groove part is made for connecting the thorn-groove (Fig. 2, 2) and a semi-cylindrical protrusion (Fig. 2, 3). On the distal base, a tongue/groove (Fig. 2, 4) is made along the edges of the part to connect the "thorn-groove" with the other part and in the middle along the axis of the cylinder there is a longitudinal open groove (Fig. 2, 5), corresponding in depth to 50% of the rod width syringe. The teeth-stops are made with open grooves (Fig. 2, 6) so that their lower level corresponds to the lower level of the base groove. The other part of the device is a solid half-cylinder, corresponding in size to the first half-cylinder and containing five transverse grooves on the inner surface, located so that the distal edge of the four grooves (Fig. 2, 7) corresponds to the edge of each stop-tooth, the distal edge of the fifth groove (Fig. 2, 8) corresponds to the edge of the distal base of the part with teeth stops, the depth of the groove is 30-35% of the diameter of the syringe rod stop in the cross section through the axis of the cylinder. A longitudinal open groove is made in the middle along the axis of the cylinder, corresponding in depth to 50% of the width of the syringe rod. The mate tongue/groove is made for connecting the "thorn-groove" with the part with stops-teeth and a semi-cylindrical ledge.

The proposed device is used as follows. Choose a skin area free from deep burns. Klein's solution is injected into the subcutaneous tissue. A 3 mm skin incision is made. A blunt cannula is inserted to collect adipose tissue, a syringe is attached to the cannula. Next, the proposed device is installed step by step on the syringe. The syringe rod is placed in the groove of the first half-cylinder containing the one-way locking mechanism and, using the groove as a guide, the rod stop is pulled in the proximal direction along the tooth stops and, upon reaching the required negative pressure in the syringe lumen, the rod is fixed on the tooth stop. In this case, the stop of the rod rests against the proximal side of the stop-tooth, which, with a reverse force, stops it and prevents it from moving in the opposite direction, as a result of which a negative pressure is created and maintained inside the syringe body. The level of fixation (on the first, second, third or fourth tooth) affects the degree of vacuum in the syringe and, thus, determines the amount of lipoaspirate obtained: in patients with a small thickness of subcutaneous tissue, a one-time tissue sampling of 20-30% of the syringe volume is planned and the stem is fixed on 1-2 teeth; with excessive fiber thickness, it is possible to safely increase the level of vacuum in the syringe with an increase in a one-time intake up to 70-90% of the volume of the syringe, while the rod is fixed on 3 or 4 teeth. Then the second half-cylinder of the device is placed on top of the first half-cylinder of the first part of the device and secured with three tongue-and-groove locks, thereby the final fixation of the rod and stop of the syringe rod and the design acquires its final cylindrical shape. The semi-cylindrical protrusions at the proximal end of the device, when connected, also form a cylindrical protrusion, which, if necessary, can be used for fixation in the chuck of a medical drill. When assembled, the device allows reciprocating and rotational movements of the syringe and cannula.

Examples of using the device.

Example 1

Patient C., 35 years old, was urgently hospitalized in a burn center with a diagnosis: “Flame burn II-III degree of the head, neck, trunk, upper and lower extremities on an area of 40% of the body surface. Burn disease in the stage of toxemia. Under aseptic conditions of the dressing room, after double treatment of the surgical field with an antiseptic solution, an undamaged area of the skin and subcutaneous tissue was selected for adipose tissue sampling. Dimensions of the area for tissue sampling: maximum linear dimension 8.0 cm, maximum transverse dimension 7.0 cm, depth of subcutaneous tissue according to ultrasound data 2.0 cm. The proposed device was used, in which the grooves are made with a maximum depth of 30% of the diameter of the syringe stem stop and the maximum distance from the inner surface of the semi-cylinder to the edge of the stop-tooth 30% of the diameter of the stop of the syringe rod. The subcutaneous tissue was infiltrated with Klein's solution in a volume of 100 ml. A skin incision 0.3 cm long was made. A blunt cannula 3 mm in diameter and 15 cm long was introduced into the subcutaneous tissue. A syringe was placed on the cannula. The syringe rod and the rod stop are installed in the first half-cylinder, drawn by 4 teeth, as a result of which a negative pressure is created in the syringe lumen. The second half-cylinder is attached to the first. Since the maximum linear size of the donor area is less than the length of the cannula, and the depth of the subcutaneous tissue layer is no more than 2.0 cm, a decision was made to use a rotary technique for taking adipose tissue. Cylindrical protrusion on the proximal end is fixed in the chuck of a medical drill. Adipose tissue sampling was performed using rotational movements, without complications.

Example 2

Patient Ch., 52 years old, was urgently hospitalized in a burn center with a diagnosis: “Flame burn II-III degree of the face, left lower limb on an area of 10% of the body surface. Burn disease in the stage of toxemia.

Under aseptic conditions of the dressing room, after double treatment of the surgical field with an antiseptic solution, an undamaged area of the skin and subcutaneous tissue was selected for adipose tissue sampling. Dimensions of the liposuction site: maximum linear dimension 35.0 cm, maximum transverse dimension 18.0 cm, depth of subcutaneous tissue according to ultrasound data 4.5 cm. the maximum distance from the inner surface of the semi-cylinder to the edge of the stop-tooth is 35% of the diameter of the stop of the syringe rod. The subcutaneous tissue was infiltrated with Klein's solution in a volume of 100 ml. A skin incision 0.3 cm long was made. A blunt cannula 3 mm in diameter and 15 cm long was introduced into the subcutaneous tissue. A syringe was placed on the cannula. The syringe rod and the rod stop are installed in the first half-cylinder, drawn by 4 teeth, as a result of which a negative pressure is created in the syringe lumen. The second half-cylinder is attached to the first. Since the maximum linear size of the donor site is greater than the length of the cannula, the depth of the subcutaneous tissue is sufficient for safe and effective reciprocating movements, it was decided to use the traditional method of cannula movements during liposuction. Conducted liposuction with reciprocating movements of the cannula. Received 50 ml of adipose tissue.

Literature sources:

1. Sattler G, Eichner S. Komplikationen bei Eingriffen am Fettgewebe [Complications of liposuction]. Hautarzt. 2013 Mar;64(3):171-9. German. doi: 10.1007/s00105-012-2487-8. PMID: 23494094.

2. Kim YH, Cha SM, Naidu S, Hwang WJ. Analysis of postoperative complications for superficial liposuction: a review of 2398 cases. Plast Reconstr Surg 2011;127:863-871.

3. You JS, Chung YE, Baek SE, Chung SP, Kim MJ. Imaging Findings of Liposuction with an Emphasis on Postsurgical Complications. Korean J Radiol. 2015 Nov-Dec;16(6):1197-206. doi: 10.3348/kjr.2015.16.6.1197. Epub 2015 Oct 26. PMID: 26576108; PMCID: PMC4644740.

4. Frank SJ, Flusberg M, Friedman S, Swinburne N, Sternschein M, Wolf EL, et al. CT appearance of common cosmetic and reconstructive surgical procedures and their complications. Clin Radiol 2013;68:e72-e78.

5. Lim H, Kim HJ, Cho YS. Active bleeding in abdominal wall developing after liposuction. Emerge Med J 2008;25:814.

6. Dixit VV, Wagh MS. Unfavorable outcomes of liposuction and their management. Indian J Plast Surg 2013;46:377-392.

7. Lehnhardt M, Homann HH, Daigeler A, Hauser J, Palka P, Steinau HU. Major and lethal complications of liposuction: a review of 72 cases in Germany between 1998 and 2002. Plast Reconstr Surg. 2008 Jun;121(6):396e-403e. doi: 10.1097/PRS.0b013e318170817a. PMID: 18520866.

8. Berger O, Cherniavsky E, Talisman R. Severe Postoperative Bleeding Following Minor-to-Moderate Abdominal and Flank Liposuction Performed at a Day Surgery Center: A Case Report. Am J Case Rep. 2022 Feb 5;23:e934049. doi: 10.12659/AJCR.934049. PMID: 35121723; PMCID: PMC8826114.

9. Liu Z, Zhang W, Zhang B, Ma L, Zhou F, Hu Z, Jie X, Gao H, Zhu X. Toxic shock syndrome complicated with symmetrical peripheral gangrene after liposuction and fat transfer: a case report and literature review. BMC Infect Dis. 2021 Nov 6;21(1):1137. doi: 10.1186/s12879-021-06777-2. PMID: 34742247; PMCID: PMC8571909.

10. Beaudoin AL, Torso L, Richards K, Said M, Van Beneden C, Longenberger A, Ostroff S, Wendt J, Dooling K, Wise M, Blythe D, Wilson L, Moll M, Perz JF. Invasive group A Streptococcus infections associated with liposuction surgery at outpatient facilities not subject to state or federal regulation. JAMA Intern Med. 2014 Jul;174(7):1136-42. doi: 10.1001/jamainternmed.2014.1875. PMID: 24861675.

11. Cuevas Bustos R, Cervantes Gutierrez O, Perez Tristan FA, Acuña Macouzet A, Flores-Huidobro Martinez A, Jafif Cojab M. Necrotizing soft tissue infection after liposculpture; case report. Int J Surg Case Rep. 2020;77:677-681. doi: 10.1016/j.ijscr.2020.11.078. Epub 2020 Nov 22. PMID: 33395872; PMCID: PMC7710500.

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Claims (1)

A device for sampling subcutaneous adipose tissue in patients with extensive skin burns, consisting of two semi-cylindrical parts with a semi-cylindrical protrusion from the proximal end for fixation in a medical drill chuck, which are assembled into a single cylindrical structure by means of tenon-groove joints, characterized in that one part - a hollow half-cylinder containing an intra-lock mechanism of one-way travel, represented by four stops-teeth, the maximum distance from the inner surface of the half-cylinder to the edge of the stop-tooth is 30-35% of the diameter of the syringe rod stop, on the cross section through the axis of the cylinder, the distal side of the stops-teeth has a slope of 35 °, and the proximal side of the stops-teeth has a slope of 90°, on the distal base in the middle along the axis of the cylinder a longitudinal open groove is made, corresponding in depth to 50% of the width of the syringe rod, open grooves are made on the teeth-stops so that their lower level corresponds to the lower level base groove; the other part of the device is a solid semi-cylinder, corresponding in size to the first semi-cylinder and containing transverse grooves on the inner surface, located so that the distal edge of each groove corresponds to the edge of each stop-tooth, the depth of the groove is 30-35% of the diameter of the syringe rod stop, in the middle along the axis The cylinder has a longitudinal open groove corresponding in depth to 50% of the width of the syringe rod.

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